Cranial 2.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04056481000493), received between Nov 2, 2016 and Sep 30, 2021 — classified as 11 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (26 reports).

2 other recalls cover devices cleared under the same FDA submission (K092467); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2021Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A PLANNED BIOPSY WITH LASER INTERSTITIAL THERAPY (LITT) TO FOLLOW, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 2.1. A PRE-OPERATIVE CT AND MRI WERE ACQUIRED 8 AND 31 DAYS PRIOR TO THE SURGERY, RESPECTIVELY, BOTH FOR USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: PLANNED A TRAJECTORY ON THE MRI IN THE NAVIGATION SOFTWARE, AND PERFORMED AN IMAGE FUSION (SOFTWARE ALIGNMENT OF DATA SETS) OF THE PREOPERATIVE CT AND MRI. POSITIONED THE PATIENT LATERAL ON THE OR TABLE WITH THEIR HEAD TURNED EXTREMELY LATERAL IN A NON-BRAINLAB HEADHOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP CT ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED THE ACCURACY OF THIS REGISTRATION AND ACCEPTED IT TO PROCEED. USED THE NAVIGATED POINTER TO MARK THE ENTRY POINT ON THE PATIENT'S SKIN, DRAPED THE PATIENT, EXCHANGED THE UNSTERILE ARRAY WITH THE STERILE ARRAY, AND CONFIRMED ACCURACY OF NAVIGATION WAS STILL ACCEPTABLE. ALIGNED THE VARIOGUIDE TO THE PRE-PLANNED TRAJECTORY USING NAVIGATION, MADE THE SKIN INCISION, CREATED THE BURR HOLE DRILLING THRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554557 ↗
• InjuryApr 13, 2020Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A DIAGNOSTIC BIOPSY OF A LESION IN THE BRAIN, LOCATED IN THE RIGHT FRONTAL LOBE, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 2.1. SEVERAL PREOPERATIVE SCANS WERE ACQUIRED TO USE WITH NAVIGATION: FOUR CT SCANS ACQUIRED TWO DAYS BEFORE THE SURGERY AND EIGHT MR SCANS ACQUIRED THREE DAYS BEFORE THE SURGERY. DURING THE PROCEDURE THE SURGEON: PERFORMED IMAGE FUSIONS (DATASET CORRELATION) OF THE TWELVE DATASETS IN THE NAVIGATION SOFTWARE AND ACCEPTED THE FUSIONS TO PROCEED. PLANNED A TRAJECTORY ON AN MRI SCAN IN THE NAVIGATION SOFTWARE AND DISPLAYED THIS MRI AND A CT IN THE NAVIGATION SOFTWARE. POSITIONED THE PATIENT IN SUPINE POSITION IN A NON-BRAINLAB HEADHOLDER AND ATTACHED THE NAVIGATION REFERENCE ARRAY. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE DISPLAYED PREOPERATIVE CT USING THE SOFTOUCH ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION ON ANATOMICAL LANDMARKS AND ACCEPTED THE REGISTRATION TO PROCEED. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY, DRAPED THE PATIENT, ATTACHED A STERILE REFERENCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9953568 ↗
• InjuryJan 22, 2020Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR DIAGNOSTIC BIOPSY OF A LEFT FRONTAL TUMOR APPROXIMATELY 13MM IN DIAMETER, 1.2CM³ IN VOLUME AND CA. 2-3CM BELOW THE DURA, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 2.1. A PREOPERATIVE MRI SCAN WAS ACQUIRED 23 DAYS PRIOR TO THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE POSITION IN A NON-BRAINLAB HEADHOLDER. PLANNED A TRAJECTORY IN THE BRAINLAB SOFTWARE. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE MRI USING THE SOFTOUCH ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT. ATTACHED A STERILE REFERENCE ARRAY, AND RE-VERIFIED NAVIGATION ACCURACY WITH THE STERILE POINTER. CREATED THE BURR HOLE AND EDITED THE PLANNED TRAJECTORY TO AVOID A LARGE VEIN. DETECTED A DEVIATION OF THE NAVIGATION DISPLAY COMPARED TO THE PATIENT'S BRAIN ANATOMY - WHILE HOLDING THE TIP OF THE NAVIGATED STERILE POINTER AT THE SURFACE OF THE PATIENT'S BRA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9617497 ↗
• InjuryDec 11, 2019Use of Device Problem; Use of Device Problem; Defective Device; Therapeutic or Diagnostic Output Failure

  A CRANIOTOMY FOR A TUMOR RESECTION WAS PERFORMED ON (B)(6) 2019 WITH THE AID OF BRAINLAB NAVIGATION SYSTEM CRANIAL 2.1. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A NON-BRAINLAB HEADHOLDER AND ATTACHED THE UNSTERILE NAVIGATION REFERENCE ARRAY. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF REGISTRATION AND, AFTER MULTIPLE REGISTRATION ATTEMPTS, DETERMINED THE REGISTRATION ACCURACY AS ACCEPTABLE FOR THE PROCEDURE, ALTHOUGH NOT PERFECT. REMOVED THE UNSTERILE REFERENCE ARRAY, DRAPED THE PATIENT, ATTACHED THE STERILE REFERENCE ARRAY, AND VERIFIED ACCURACY AGAIN AND NOTED THE SAME LEVEL OF ACCEPTABLE ACCURACY. RESECTED THE TUMOR, SENT TISSUE SAMPLES TO PATHOLOGY FOR ANALYSIS, AND COMPLETED THE SURGERY. PATHOLOGY RESULTS DID NOT SHOW ANY TUMOR TISSUE IN THE SAMPLES. POST-OPERATIVE SCANS PERFORMED THE NEXT DAY SHOWED THAT THE TUMOR WAS NOT RESECTED. ACCORDING TO THE HOSPITAL, THE PATIENT DID NOT SUFFER ANY NEGATIVE CLINICAL EFFECTS DUE TO THE SURGERY, AND NO REVISION SURGERY IS PLANNED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9449297 ↗
• InjurySep 17, 2019Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR REMOVAL OF A SMALL SPHERICAL TUMOR APPROXIMATELY 9 MM IN DIAMETER LOCATED IN THE CEREBELLUM, POSTERIOR TO THE BRAINSTEM AND LEFT OF THE THIRD VENTRICLE, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 2.1. A PREOPERATIVE MRI SCAN WAS ACQUIRED ON (B)(6) 2019, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN PRONE POSITION IN A NON-BRAINLAB HEADHOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE MRI USING THE SOFT TOUCH ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT. ATTACHED A STERILE REFERENCE ARRAY, AND RE-VERIFIED NAVIGATION ACCURACY WITH THE STERILE POINTER. REMOVED AN EXISTING BONE FLAP FROM A PREVIOUS SURGERY AND OPENED THE DURA. RESECTED THE TUMOR USING THE AID OF NAVIGATION TO CONFIRM THE LOCATION AS THE DISSECTION PATH WAS CREATED. COMPLETED THE SURGERY, AND SENT TISSUE SAMPLES FOR ANALYSIS BY PATHOLOGY. RESULTS OF THE TISSUE ANALYSIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9076090 ↗
• InjuryJun 17, 2019Use of Device Problem; Material Deformation; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Malposition of Device; Material Deformation

  A CRANIAL SURGERY FOR BIOPSY (DIAGNOSTIC SAMPLE) OF A BRAIN TUMOR WAS PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 2.1. AN MRI SCAN WAS ACQUIRED PRE-OPERATIVELY ON (B)(6) 2019 TO USE WITH NAVIGATION. TRAJECTORY AND REGISTRATION POINTS WERE PLANNED ON THE SCANS PRE-OPERATIVELY IN THE BRAINLAB NAVIGATION SOFTWARE THE DAY OF THE SURGERY. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER AND ATTACHED THE UNSTERILE REFERENCE ARRAY. - PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI USING THE POINTER ACQUIRING 10 REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - VERIFIED THE ACCURACY OF THE REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED. - UPDATED THE PLANNED ENTRY POINT OF THE PRE-PLANNED TRAJECTORY USING THE POINTER AND THE AID OF NAVIGATION. - REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT. - ATTACHED A STERILE REFERENCE ARRAY, RE-VERIFIED NAVIGATION ACCURACY, AND DETERMINED THE BURR HOLE PLACEMENT WITH THE AID OF NAVIGATION. - ATTACHED AND ALIGNED THE VARIOGUIDE TO THE PLANNED TRAJECTORY. - US

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704048 ↗
• InjuryFeb 13, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY AN EXTENDED ENDOSCOPIC BIOPSY (FOR DIAGNOSTIC TISSUE AND TISSUE FOR THE RESEARCH LAB) OF A LOW GRADE GLIOMA, LOCATED CA. 8CM DEEP IN THE TEMPORAL LOBE OF THE BRAIN, WITH SIZE OF CA. 22CM², HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 2.1.2. A PRE-OPERATIVE MRI SCAN WAS ACQUIRED 2 DAYS BEFORE THE SURGERY, TO USE WITH NAVIGATION. A TRAJECTORY WAS PLANNED ON THE MRI SCAN. DURING THE PROCEDURE, THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT. ATTACHED A STERILE REFERENCE ARRAY, RE-VERIFIED NAVIGATION ACCURACY, DETERMINED LOCATION OF THE BURR HOLE FOR THE DESIRED APPROACH WITH NAVIGATION, AND CREATED A SINGLE BURR HOLE (CRANIOTOMY) TO THE PLANNED TRAJECTORY. ATTACHED A (NON-BRAINLAB) NON-NAVIGATED ADHESIVE INTRODUCER SHEATH AT THE BURR HOLE ENTRY TO USE AS AN INSTRUMENT G

  Patient problems: Brain Injury; Facial Nerve Paralysis; Memory Loss/Impairment; Paresis

  MAUDE report 8334588 ↗
• InjuryDec 19, 2018Use of Device Problem; Device Handling Problem; Use of Device Problem; Activation, Positioning or Separation Problem; Device Handling Problem

  A CRANIAL SURGERY FOR TUMOR (VASCULAR MALFORMATION) RESECTION WAS PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 2.1. ACCORDING TO THE SURGEON'S PLANNING THE TUMOR HAD A SIZE OF APPROXIMATELY 1.5X1.6X1.3 MM AND WAS LOCATED NEAR THE BRAINSTEM AND CEREBELLUM. A PRE-OPERATIVE MRI SCAN FOR USE WITH BRAINLAB NAVIGATION WAS ACQUIRED THREE DAYS PRIOR TO THE DAY OF SURGERY. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN PRONE ORIENTATION CLAMPED, INTO A (NON-BRAINLAB) HEAD HOLDER, ATTACHED WITH THE BRAINLAB NAVIGATION REFERENCE ARRAY. PERFORMED THE INITIAL PATIENT REGISTRATION (SURFACE MATCHING REGISTRATION WITH BRAINLAB SOFTOUCH) TO MATCH THE VIRTUAL DISPLAY OF PREOPERATIVE MRI SCAN TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF REGISTRATION AND, AFTER A SECOND REGISTRATION ATTEMPT, DETERMINED THE REGISTRATION ACCURACY AS APPROPRIATE. DRAPED THE PATIENT AND PERFORMED INCISION AND BURR HOLE WITH THE AID OF NAVIGATION. INSERTED THE NICO BRAINPATH DEVICE (NON-BRAINLAB DEVICE) WITH THE AID OF NAVIGATION AND VERIFIED ITS PLACEMENT. DETECTED A DEVIATION OF ABOUT 10 MM INFERIOR BETWEEN THE INFORMATION PROVIDED BY THE NAVIGATION SYSTEM AND THE ACTU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8177881 ↗
• InjuryDec 11, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR PLACEMENT OF 9 ELECTRODES (6 ON THE RIGHT SIDE AND 3 ON THE LEFT SIDE) WAS PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION (B)(4) ON (B)(6) 2018. THE TRAJECTORIES WERE PLANNED FOR THIS PATIENT ON (B)(6) 2018 USING THE BRAINLAB SOFTWARE IPLAN CRANIAL (B)(4). PRE-OPERATIVE DATA SETS FOR USE WITH BRAINLAB PLANNING AND NAVIGATION WERE ACQUIRED ON JUN 18, 2018 (CT DATA SETS) AND (B)(6) 2018 (MR DATA SETS). DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE ORIENTATION CLAMPED INTO A (NON-BRAINLAB) HEAD HOLDER, ATTACHED WITH THE BRAINLAB NAVIGATION REFERENCE ARRAY. PERFORMED THE INITIAL PATIENT REGISTRATION (SURFACE MATCHING REGISTRATION WITH BRAINLAB SOFTOUCH) TO MATCH THE VIRTUAL DISPLAY OF PREOPERATIVE SCAN TO THE CURRENT PATIENT ANATOMY AND VERIFIED THE ACCURACY OF REGISTRATION WITH A SATISFYING RESULT. DRAPED THE PATIENT, INCLUDING EXCHANGING THE NAVIGATION REFERENCE ARRAY FROM UNSTERILE TO STERILE. PLACED 6 ELECTRODES ON THE RIGHT SIDE OF THE PATIENT'S HEAD SUCCESSFULLY AS INTENDED, WITH THE AID OF BRAINLAB NAVIGATION (VARIOGUIDE). UNDRAPED THE PATIENT, INCLUDING EXCHANGING THE NAVIGATION REFERENCE ARRAY FROM STERILE TO

  Patient problems: Hematoma

  MAUDE report 8149729 ↗
• MalfunctionNov 27, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR A BIOPSY FOR RETRIEVAL OF A DIAGNOSTIC SAMPLE OF A CEREBELLAR LESION (GLIOMA), LOCATED CA. 70 MM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 2.1.2. ONE PASS FOR ONE SAMPLE WAS INTENDED. A PRE-OPERATIVE MRI SCAN WAS ACQUIRED AT THE SAME DAY OF SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A PRONE ORIENTATION IN A HEAD HOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI USING FIDUCIALS TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT. ATTACHED A STERILE REFERENCE ARRAY, RE-VERIFIED ACCURACY, DETERMINED LOCATION OF THE BURR HOLE FOR THE DESIRED APPROACH WITH NAVIGATION, AND CREATED A BURR HOLE (CRANIOTOMY) OF CA. 15 MM. EQUIPPED A BENDABLE NON-BRAINLAB BIOPSY NEEDLE WITH AN ARRAY, AND CALIBRATED THE NEEDLE TO THE NAVIGATION. THE FRAMELESS BIOPSY SYSTEM WAS USED AS INSTRUMENT HOLDER ONLY. PERFORMED 4 PASSES TO TAKE BIOPSY SAMPLES, THE SAMPLES WERE NON-PATHOLOGICAL AND NORMAL BRAIN TISS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8105527 ↗
• InjuryOct 31, 2018Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  A MINIMALLY INVASIVE SPINE SURGERY FOR STABILIZATION OF L3-L4 (DUE TO SPONDYLOLISTHESIS) WAS PLANNED TO BE PERFORMED WITH THE AID OF BRAINLAB NAVIGATION SYSTEM SPINE AND TRAUMA 3D 2.6 (ON (B)(6) 2018). DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN PRONE POSITION ON THE OR TABLE ATTACHED THE RADIOLUCENT REFERENCE CLAMP TO THE SPINOUS PROCESS OF L3 (INCL. THE 3-SPHERE REFERENCE ARRAY). PERFORMED AN INTRAOPERATIVE SCAN WITH THE ZIEHM VISION RFD 3D C-ARM, THAT WAS AUTOMATICALLY MATCHED BY THE NAVIGATION SYSTEM WITH THE CURRENT PATIENT ANATOMY (AUTOMATIC IMAGE REGISTRATION) VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED IT TO BE APPROPRIATE PLACED TWO K-WIRES IN L3 (LEFT AND RIGHT) WITH THE AID OF NAVIGATION (USING THE PEDICLE ACCESS NEEDLE). OBTAINED AN X-RAY IMAGE, THAT REVEALED THAT BOTH THE K-WIRES WERE NOT PLACED AS INTENDED. (DEVIATION WAS QUANTIFIED >1CM FOR ONE K-WIRE, 0.5 - 1 CM FOR THE OTHER K-WIRE). DECIDED TO REPLACE THE K-WIRES WITHOUT AID OF NAVIGATION (USING X-RAY FOR VERIFICATION). PLACED THE REMAINING TWO K-WIRES (IN L4) AND FOUR SCREWS (IN L3 AND L4) WITHOUT AID OF NAVIGATION (USING X-RAY FOR VERIFICATION). ACCORDING TO THE HOSPITAL, THE FINAL O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8022727 ↗
• MalfunctionOct 26, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR CATHETER PLACEMENT FOR CONVECTION-ENHANCED DRUG DELIVERY (CED) TO A TUMOR WITH A SIZE OF CA 2.5CM, LOCATED IN THE RIGHT FRONTAL/TEMPORAL LOBES CA. 1.2CM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 2.1.2. SEVERAL PRE-OPERATIVE MRI SCANS WERE ACQUIRED, INCLUDING AN MRI SCAN ACQUIRED ONE DAY BEFORE THE SURGERY, TO USE WITH NAVIGATION. TRAJECTORIES WERE PLANNED FOR THE PROCEDURE, PLACEMENT OF TWO CATHETERS WAS INTENDED. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION CLAMPED INTO A (NON-BRAINLAB) HEAD HOLDER, ATTACHED THE BRAINLAB NAVIGATION REFERENCE ARRAY THAT WAS USED FOR NAVIGATION. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI WITH FIDUCIAL MARKERS ATTACHED ON THE SKIN OF THE PATIENT, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION ON THE PATIENT'S SKIN WITH ANATOMICAL LANDMARKS, AND JUDGED THE NAVIGATION ACCURACY ACHIEVED AS VERY GOOD AND ACCEPTABLE FOR USE FOR THIS CASE. DRAPED THE PATIENT, AND EXCHANGED THE NAVIGATION REFERENCE ARRAY FROM UNSTERILE TO STERILE. USED THE BRAINLAB NAVIGATED VARIOGUIDE TO AL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8008189 ↗
• InjuryOct 24, 2018Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  A RIGHT SIDE BRAINSTEM BIOPSY WAS PLANNED TO BE PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 2.1.2 (ON (B)(6) 2018). THE TUMOR DIMENSION WAS ABOUT 19.5 MM IN DIAMETER, AND LOCATED ABOUT 65 MM FROM THE SURFACE. SURGERY GOAL WAS TO OBTAIN A DIAGNOSTIC SAMPLE (NOT TO REMOVE/TREAT LESION), WITH BIOPSY WINDOW ABOVE THE TARGET. 7 DONUT MARKERS WERE PLACED ON THE PATIENT HEAD, AND PRE-OPERATIVE MRI SCANS (T1 AND T2) WERE ACQUIRED ON THE SURGERY DAY, FOR USE WITH NAVIGATION. DURING THE SURGERY, THE SURGEON/HEALTH PROFESSIONAL: POSITIONED THE PATIENT IN SUPINE ORIENTATION (WITH HEAD TILTED TO THE LEFT) AND ATTACHED THE 3 SPHERE STANDARD CRANIAL REFERENCE ARRAY FOR NAVIGATION PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OPERATIVE MRI T1 SCAN (TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY) VERIFIED ACCURACY OF THE REGISTRATION, AND DETERMINED IT GOOD FOR THIS PROCEDURE DRAPED THE PATIENT AND EXCHANGED THE UNSTERILE REFERENCE ARRAY FOR A STERILE ONE (VERIFIED ACCURACY ONLY IN REGION OF INTEREST, NO FURTHER ACCURACY VERIFICATION WAS POSSIBLE SINCE DRAPED FOR BURR HOLE). ASSEMBLED THE VARIOGUIDE. PLANNED THE BURR HOLE ENTRY USING AID O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7999091 ↗
• MalfunctionAug 17, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR EXCISION OF A SMALL RIGHT POSTERIOR FRONTAL CONVEXITY MENINGIOMA, WITH A SIZE OF CA. 18 X 12 MM LOCATED SUPERFICIALLY IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 2.1.2. A PRE-OPERATIVE MRI SCAN WAS ACQUIRED ONE DAY BEFORE THE SURGERY, TO USE WITH NAVIGATION. THE TUMOR HAD BEEN OUTLINED FOR THE PROCEDURE. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, AND FIXATED THE BRAINLAB REFERENCE ARRAY FOR NAVIGATION. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI WITH REGISTRATION POINTS TAKEN ON THE SKIN OF THE PATIENT TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE SECOND REGISTRATION ATTEMPT ON THE PATIENT'S SKIN WITH ANATOMICAL LANDMARKS, AND JUDGED THE NAVIGATION ACCURACY ACHIEVED AS GOOD AND ACCEPTABLE FOR USE FOR THIS CASE. DRAPED THE PATIENT, PLACED THE STERILE NAVIGATION REFERENCE ARRAY AND RE-VERIFIED THE NAVIGATION ACCURACY. DETERMINED THE CRANIOTOMY LOCATION WITH THE AID OF NAVIGATION AND CREATED THE CRANIOTOMY. RECOGNIZED AFTER OPENING THE DURA THAT UNDER THE CRANIOTOMY LOCATION WAS NORMAL BRAIN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792574 ↗
• MalfunctionJul 16, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR SHUNT CATHETER PLACEMENT TO ASPIRATE CSF FROM A CYST WITH A SIZE OF CA. 12.5 CCM LOCATED IN THE BRAIN AT A DEPTH OF CA. 35 MM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 2.1.2. A PRE-OPERATIVE CT SCAN WAS ACQUIRED BEFORE THE SURGERY AT THE SAME DAY, TO USE WITH NAVIGATION. A TRAJECTORY WAS PLANNED FOR THE PROCEDURE. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A LATERAL ORIENTATION, USING THE REFERENCE HEADBAND WITH ARRAY FOR NAVIGATION REFERENCE. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP CT WITH REGISTRATION POINTS TAKEN ON THE SKIN OF THE PATIENT TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION ON THE PATIENT'S SKIN WITH ANATOMICAL LANDMARKS, AND JUDGED THE NAVIGATION ACCURACY ACHIEVED AS GOOD AND ACCEPTABLE FOR USE FOR THIS CASE. DRAPED THE PATIENT, PLACED THE STERILE NAVIGATION REFERENCE ARRAY AND RE-VERIFIED THE NAVIGATION ACCURACY. CREATED THE BURR HOLE (CRANIOTOMY) AND INSERTED THE CATHETER WITH THE HELP OF A NAVIGATED STYLET ALIGNING TO THE PLANNED TRAJECTORY. AFTER TWO PLACEMENT ATTEMPTS WITHOUT SUCCESSFUL RETURN OF CSF, NOTICED THAT T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689953 ↗
• MalfunctionApr 19, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Human Factors Issue; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Human Factors Issue; Device Handling Problem

  A CRANIAL SURGERY FOR A BIOPSY (FOR RETRIEVAL OF A DIAGNOSTIC SAMPLE) OF A LESION WITH A SIZE OF CA. 15 MM, LOCATED CA. 42 MM DEEP IN THE LEFT TEMPORAL LOBE, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 2.1.2 . A PRE-OPERATIVE MRI SCAN WAS ACQUIRED 5 DAYS BEFORE THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A HEAD HOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI WITH SURFACE MATCHING TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. SEVERAL ATTEMPTS FOR REGISTERING WERE PERFORMED. VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED THE RESULT AS LESS THAN OPTIMAL, BUT DECIDED TO PROCEED WITH MEDIUM PRECISION. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT. ATTACHED A STERILE REFERENCE ARRAY, RE-VERIFIED ACCURACY, DETERMINED LOCATION OF THE BURR HOLE AND TRAJECTORY WITH THE POINTER, AND CREATED A BURR HOLE (CRANIOTOMY). ALIGNED A NAVIGATED BIOPSY NEEDLE AND PERFORMED THE BIOPSY, 1 PASS WITH 2 SAMPLES. PATHOLOGY INFORMED THAT THESE SAMPLES ARE NON-DIAGNOSTIC. PERFORMED ANOTHER BIOPSY PASS FREEHANDED WITHOUT USING NAVIG

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7443129 ↗
• MalfunctionApr 5, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Human Factors Issue; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Human Factors Issue; Device Handling Problem

  A CRANIAL SURGERY FOR A BIOPSY (FOR RETRIEVAL OF A DIAGNOSTIC SAMPLE) OF A LESION WITH A SIZE OF CA. 1 CCM, LOCATED CA. 65 MM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 2.1.2. A PRE-OPERATIVE MRI SCAN WAS ACQUIRED 3 DAYS BEFORE THE SURGERY, TO USE WITH NAVIGATION. A TRAJECTORY WAS PLANNED FOR THE PROCEDURE. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI WITH SURFACE MATCHING TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED THE RESULT AS GOOD. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY, SENT THE ARRAY TO IMMEDIATE USE STEAM STERILIZATION, AND DRAPED THE PATIENT. ATTACHED THE NEWLY STERILIZED REFERENCE ARRAY, RE-VERIFIED POSITION OF THE ENTRY POINT USING THE NAVIGATED POINTER, AND CREATED A BURR HOLE. ALIGNED THE NAVIGATED INSTRUMENT GUIDE TO THE PLANNED TRAJECTORY WITH ENTRY POINT. PERFORMED THE BIOPSY WITH A NAVIGATED BIOPSY NEEDLE ALIGNING TO THE PLANNED TRAJECTORY. ONE (1) BIOPSY PASS WITH 4 SAMPLES WAS PERFORMED AS ORIGINALLY INTENDED. PATHOLOGY INFORMED THAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7398585 ↗
• MalfunctionNov 24, 2017Use of Device Problem; Improper or Incorrect Procedure or Method; Human Factors Issue; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Human Factors Issue; Device Handling Problem

  A CRANIAL SURGERY FOR A BIOPSY (FOR RETRIEVAL OF A DIAGNOSTIC SAMPLE) OF A LESION WITH A SIZE OF CA. 20 MM, LOCATED CA. 55 MM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 2.1.2. TWO PRE-OPERATIVE MRI SCANS WERE ACQUIRED 4 DAYS BEFORE THE SURGERY, TO USE WITH NAVIGATION. A TRAJECTORY WAS PLANNED FOR THE PROCEDURE IN ONE OF THE MRI SCANS, AND THE SCANS WERE FUSED. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A HEAD HOLDER. - PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI WITH SURFACE MATCHING TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED THE RESULT AS GOOD. - REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT. - ATTACHED A STERILE REFERENCE ARRAY, RE-VERIFIED ACCURACY, DETERMINED LOCATION OF THE BURR HOLE, ADAPTED THE PLANNED TRAJECTORY ENTRY POINT, AND CREATED A BURR HOLE (CRANIOTOMY, CA. 2 CM DIAMETER). - ALIGNED THE NAVIGATED INSTRUMENT GUIDE TO THE PLANNED TRAJECTORY WITH THE NEW ENTRY POINT. - PERFORMED THE BIOPSY WITH A NAVIGATED BIOPSY NEEDLE ALIGNING TO THE PLANNED TRAJECTORY WI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7057701 ↗
• MalfunctionJul 17, 2017Use of Device Problem; Improper or Incorrect Procedure or Method; Human Factors Issue; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Human Factors Issue; Device Handling Problem

  A CRANIAL SURGERY FOR CATHETER PLACEMENT TO DRAIN AN INTRA-CEREBRAL HEMORRHAGE (BASAL GANGLIA), WITH A SIZE OF CA. 43 CM³, WAS PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 2.1.2. A PRE-OPERATIVE CT SCAN WAS ACQUIRED ONE DAY BEFORE THE SURGERY TO USE WITH NAVIGATION. A TRAJECTORY FOR CATHETER PLACEMENT WAS PLANNED USING THIS PRE-OP CT SCAN. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A SUPINE POSITION IN A NON-BRAINLAB HEAD HOLDER. - PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP CT WITH REGISTRATION POINTS TAKEN ON THE SKIN OF THE PATIENT (FACE AND FOREHEAD) TO MATCH THE VIRTUAL DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - VERIFIED THE ACCURACY OF THE REGISTRATION ON THE PATIENT'S SKIN TO BE ACCEPTABLE FOR USE. - DRAPED THE PATIENT, PERFORMED THE CRANIOTOMY (BURRHOLE), ALIGNED A NAVIGATED BIOPSY NEEDLE USED AS GUIDANCE FOR THE CATHETER AND PLACED THE CATHETER FOR DRAINAGE. - A POST-OP CT SCAN WAS PERFORMED, AND SHOWED THAT THE CATHETER WAS NOT IDEALLY PLACED. THE CATHETER DEVIATED BY CA. 6 MM FROM THE INTENDED TARGET POINT, STILL DRAINAGE OF BLOOD WAS POSSIBLE WITH THIS PLACEMENT, WITH ASPIRATION OF CA. 20 CM³.

  Patient problems: Pulmonary Embolism

  MAUDE report 6716586 ↗
• MalfunctionJun 23, 2017Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  A CRANIAL SURGERY FOR A BIOPSY (FOR RETRIEVAL OF A DIAGNOSTIC SAMPLE) OF A LESION WITH A SIZE OF CA. 5 CM, LOCATED LEFT TEMPORAL IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE VIRTUAL DISPLAY OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 2.1.2. A PRE-OPERATIVE CT SCAN WAS ACQUIRED THE DAY BEFORE THE SURGERY, TO USE WITH NAVIGATION. THE TRAJECTORY WAS PLANNED ON THE CT SCAN BEFORE THE SURGERY USING THE BRAINLAB IPLAN PLANNING SOFTWARE. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER. - PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP CT WITH REGISTRATION POINTS TAKEN ON THE SKIN OF THE PATIENT TO MATCH THE VIRTUAL DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. THE REGISTRATION RESULT SHOWED GOOD PRECISION. - VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED THE RESULT AS GOOD. - DRAPED THE PATIENT, AND EXCHANGED THE UNSTERILE NAVIGATION REFERENCE ARRAY TO A STERILE REFERENCE ARRAY. - CREATED A BURR HOLE, AND WHEN INSERTING THE NAVIGATED BIOPSY NEEDLE, THE SURGEON DETERMINED A DEVIATION OF THE NEEDLE'S DEPTH POSITION DISPLAYED BY THE NAVIGATION OF CA. 1-3 CM, COMPARED TO THE PATIENT A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6662950 ↗
• MalfunctionMar 23, 2017Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  AN OPEN CRANIAL SURGERY FOR RESECTION OF A TUMOR WITH A SIZE OF CA. 7MM X 9MM, LOCATED CA. 25MM DEEP IN THE RIGHT SIDE OF THE BRAIN, WAS INTENDED TO BE PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 2.1.2. A PRE-OPERATIVE MRI WAS ACQUIRED THE DAY BEFORE THE SURGERY TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN THE SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI WITH REGISTRATION POINTS TAKEN ON THE SKIN OF THE PATIENT TO MATCH THE VIRTUAL DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. THE REGISTRATION RESULT SHOWED GOOD PRECISION. DRAPED THE PATIENT, AND NAVIGATION REFERENCE ARRAY WAS EXCHANGED TO A STERILE ARRAY. VERIFIED THE ACCURACY OF THE REGISTRATION ON THE PATIENT'S SKIN WITH ANATOMICAL LANDMARKS TO BE ACCEPTABLE FOR USE. PERFORMED THE CRANIOTOMY. ONCE THE BONE FLAP WAS OFF, SURGEON USED THE BRAINLAB 2 SPHERE POINTER FOR NAVIGATION DIRECTIONS, AND GOT DOWN THE PATH IN THE BRAIN TISSUE TO WHERE THE TUMOR WAS SUPPOSED TO BE, BUT THEN DID NOT SEE THERE THE TUMOR ON THE NAVIGATION DISPLAY. SURGEON SAW THE TUMOR ON THE NAVIGATION, BUT COULD NOT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6427293 ↗
• MalfunctionMar 15, 2017Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  A CRANIAL SURGERY FOR IMPLANTATION OF 12 SEEG ELECTRODES INTO THE PATIENT'S BRAIN (TO TREAT EPILEPSY) WAS PERFORMED WITH THE AID OF THE VIRTUAL DISPLAY OF THE BRAINLAB NAVIGATION SW VERSION 2.1.1. A PRE-OPERATIVE CT SCAN WAS ACQUIRED THE DAY BEFORE SURGERY, TO USE WITH NAVIGATION. TRAJECTORIES FOR THE 12 ELECTRODES WERE PLANNED ON PRE-OPERATIVE CT SCANS AND MRI SCANS BEFORE THE SURGERY WITH BRAINLAB PLANNING SW IPLAN 3.0.5. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN THE SUPINE ORIENTATION IN A HEAD HOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP CT SCAN WITH SURFACE MATCHING TO MATCH THE VIRTUAL DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. SEVERAL ATTEMPTS WERE NECESSARY TO ACHIEVE A DESIRED REGISTRATION ACCURACY. DRAPED THE PATIENT, VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED THE RESULT AS GOOD. CREATED THE BURR HOLES, AND PLACED 12 SEEG ELECTRODES WITH AID OF NAVIGATION. A POST-OPERATIVE SCAN WAS PERFORMED, AND THE SURGEON DETERMINED THAT THE FIRST 5 ELECTRODES WERE IMPLANTED WITHIN DESIRED ACCURACY STANDARDS (BELOW 3 MM), HOWEVER, THE ELECTRODE LOCATIONS OF THE LAST 7 ELECTRODES DIFFERED BY CA. 3MM TO CA. 4.5MM FROM THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6405600 ↗
• MalfunctionMar 2, 2017Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  A CRANIAL SURGERY FOR A IMPLANTATION OF SEEG ELECTRODES (TO TREAT EPILEPSY) INTO THE PATIENT'S BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE VIRTUAL DISPLAY OF THE BRAINLAB NAVIGATION VERSION 2.1.1. PRE-OPERATIVE CT SCANS (CT AND CT ANGIO) WERE ACQUIRED CA. 2 WEEKS BEFORE THE SURGERY, TO USE WITH NAVIGATION. 5 TRAJECTORIES FOR THE ELECTRODES WERE PLANNED ON THE PRE-OP CT SCANS AND MRI SCANS BEFORE THE SURGERY WITH THE BRAINLAB IPLAN PLANNING SW. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A PRONE ORIENTATION IN A (NON-BRAINLAB) HEAD HOLDER. - PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP CT WITH SURFACE MATCHING TO MATCH THE VIRTUAL DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. SEVERAL ATTEMPTS WERE NECESSARY TO ACHIEVE A DESIRED REGISTRATION ACCURACY. - DRAPED THE PATIENT, VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED THE RESULT AS GOOD. - CREATED THE BURR HOLES. AT THE PENETRATION OF DURA MEMBRANE BY MONOPOLAR CAUTERIZATION FOR ONE INTENDED ELECTRODE PLACEMENT, A SMALL BLEEDING OCCURRED (PERFORATION OF VEIN: VENA LABE, THE BLEEDING IS LOCALIZED IN THE TEMPORAL LOBE GYRUS TEMPORALIS MEDIUS ON THE RIGHT SIDE). THE BLEEDING WAS DET

  Patient problems: Intracranial Hemorrhage

  MAUDE report 6371353 ↗
• MalfunctionFeb 22, 2017Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  A CRANIAL SURGERY FOR A IMPLANTATION OF 8 SEEG ELECTRODES (TO TREAT EPILEPSY) INTO THE INFANT PATIENT'S BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE VIRTUAL DISPLAY OF THE BRAINLAB NAVIGATION VERSION 2.1.1. PRE-OPERATIVE CT SCANS WERE ACQUIRED CA. 2.5 WEEKS BEFORE THE SURGERY, TO USE WITH NAVIGATION. TRAJECTORIES FOR THE ELECTRODES WERE PLANNED ON THE PRE-OP CT SCANS AND MRI SCANS BEFORE THE SURGERY WITH THE BRAINLAB IPLAN PLANNING SW. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A PRONE ORIENTATION IN A (NON-BRAINLAB) HEAD HOLDER. - PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP CT WITH SURFACE MATCHING TO MATCH THE VIRTUAL DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. SEVERAL ATTEMPTS WERE NECESSARY TO ACHIEVE A DESIRED REGISTRATION ACCURACY. - DRAPED THE PATIENT, VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED THE RESULT AS VERY GOOD. - CREATED THE BURR HOLES, AND PLACED THE 8 ELECTRODES WITH AID OF NAVIGATION. A POST-OP CT SCAN WAS PERFORMED, AND THE SURGEON DETERMINED THAT THE ELECTRODE LOCATIONS DIFFERED BY CA. 2 MM TO CA. 7 MM FROM THE INTENDED TARGET LOCATIONS. ACCORDING TO THE SURGEON: - THE RESULTS OF THE SURGERY WERE STILL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6348666 ↗
• MalfunctionFeb 22, 2017Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  A CRANIAL SURGERY FOR A IMPLANTATION OF 8 SEEG ELECTRODES (TO TREAT EPILEPSY) INTO THE PATIENT'S BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE VIRTUAL DISPLAY OF THE BRAINLAB NAVIGATION VERSION 2.1.1. PRE-OPERATIVE CT SCANS (CT AND CT ANGIO) WERE ACQUIRED 4 DAYS BEFORE THE SURGERY, TO USE WITH NAVIGATION. TRAJECTORIES FOR THE ELECTRODES WERE PLANNED ON THE PRE-OP CT SCANS AND MRI SCANS BEFORE THE SURGERY WITH THE BRAINLAB IPLAN PLANNING SW. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A PRONE ORIENTATION IN A (NON-BRAINLAB) HEAD HOLDER. - PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP CT WITH SURFACE MATCHING TO MATCH THE VIRTUAL DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - DRAPED THE PATIENT, VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED THE RESULT AS VERY GOOD. - CREATED THE BURR HOLES, AND PLACED THE 8 ELECTRODES WITH AID OF NAVIGATION. A POST-OP CT SCAN WAS PERFORMED, AND THE SURGEON DETERMINED THAT THE ELECTRODE LOCATIONS DIFFERED BY CA. 3MM TO CA. 6MM FROM THE INTENDED TARGET LOCATIONS. ACCORDING TO THE SURGEON: - THE RESULTS OF THE SURGERY WERE STILL IN ACCORDANCE WITH EXPECTATION. - THERE WERE NO NEGATIVE EFFECTS TO THE P

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6348659 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092467. One submission often covers many models, so check the product and lot details in each record.

• Z-0056-2021 · Aug 31, 2020 · Terminated
  Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided l
• Z-0598-2016 · Apr 22, 2013 · Terminated
  Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative imag