Cranial 3.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 04056481000479), received between Oct 21, 2016 and Feb 10, 2021 — classified as 22 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (36 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2021Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR COMPLETE RESECTION OF A LEFT FRONTAL TUMOR APPROXIMATELY 10MM BY 7MM IN SIZE, LOCATED APPROXIMATELY 40MM IN DEPTH AND CLOSE TO THE MIDLINE, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. A PREOPERATIVE MRI SCAN WAS ACQUIRED ONE DAY PRIOR TO THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A NON-BRAINLAB HEADHOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE 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, AND BEGAN THE SURGERY. CALIBRATED THE BRAINLAB SHORT TIP POINTER TO THE NAVIGATION DISPLAY AND ACCEPTED THE CALIBRATION RESULT TO PROCEED. USED THE NAVIGATED SHORT TIP POINTER TO AID IN INITIALLY LOCATING THE TUMOR, AND PERFORMED THE RESECTION, PERIODICALLY CHECKING THE LOCATION OF THE RESECTION WITH THE NAVIGATED POINTER. COMPLETED THE SURGERY. THE SURGEON DETERMINED FROM A POSTOPER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11308175 ↗
• InjuryFeb 1, 2021Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A DIAGNOSTIC BIOPSY AND PLACEMENT OF A NON-BRAINLAB BOLT FOR SUBSEQUENT LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR A BRAIN TUMOR APPROXIMATELY 15MM IN DIAMETER, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. SEVEN FIDUCIAL MARKERS WERE PLACED ON THE SURFACE OF THE PATIENT'S HEAD AND A PREOPERATIVE MRI SCAN WAS ACQUIRED ON THE SAME DAY AS THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE POSITION IN A NON-BRAINLAB HEADHOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE MRI BY PLANNING AND THEN ACQUIRING REGISTRATION POINTS AT THE FIDUCIAL MARKERS TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED. USED THE SOFTOUCH POINTER TO PLAN A TRAJECTORY FOR THE BIOPSY ON THE MRI IN THE NAVIGATION. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT. ATTACHED A STERILE REFERENCE ARRAY AND ALIGNED THE VARIOGUIDE TO THE PLANNED TRAJECTORY USING THE AID OF NAVIGATION. USED A NON-BRAINLAB DRILL AND DRILL KIT TO DRILL A BURR HOLE THROUGH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11260654 ↗
• InjuryNov 16, 2020Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR RESECTION OF A LEFT FRONTAL LOBE TUMOR LOCATED 8MM BELOW THE DURA, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. A PREOPERATIVE MRI SCAN WAS ACQUIRED ONE DAY PRIOR TO THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A NON-BRAINLAB HEADHOLDER. 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. MARKED THE LOCATION OF THE TUMOR ON THE SKIN SURFACE USING THE AID OF NAVIGATION. REPOSITIONED THE PATIENT'S HEAD IN THE NON-BRAINLAB HEADHOLDER, AND PERFORMED A NEW PATIENT REGISTRATION IN THE SAME MANNER AS BEFORE, AND VERIFIED AND ACCEPTED THE ACCURACY OF 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. PERFORMED THE CRANIOTOMY AND OPENED THE DURA. CALIBRATED A NON-BRAINLAB MICROSCOPE TO THE

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 10843996 ↗
• InjuryAug 18, 2020Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR DIAGNOSTIC BIOPSY OF A SPHERICAL LESION APPROXIMATELY 11MM IN DIAMETER LOCATED IN THE RIGHT SIDE OF THE BRAIN, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL (B)(6) A PREOPERATIVE MRI SCAN WAS ACQUIRED FIVE DAYS PRIOR TO THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN LATERAL POSITION IN A NON-BRAINLAB HEADHOLDER. 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. ATTACHED THE VARIOGUIDE AND ALIGNED IT TO A PRE-PLANNED TRAJECTORY PREVIOUSLY CREATED IN THE NAVIGATION SOFTWARE. DRILLED A BURR HOLE USING THE VARIOGUIDE DRILL KIT TO ALIGN THE DRILL TO THE INTENDED ENTRY POINT. PASSED THE BRAINLAB-DISTRIBUTED BIOPSY NEEDLE THROUGH THE VARIOGUIDE ALONG THE PLANNED TRAJECTORY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10421283 ↗
• InjuryAug 10, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR DIAGNOSTIC BIOPSY OF A SPHERICAL LESION APPROXIMATELY 1.22CM IN DIAMETER LOCATED IN THE RIGHT SIDE OF THE BRAIN, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. A PREOPERATIVE MRI SCAN WAS ACQUIRED THREE DAYS PRIOR TO THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A LATERAL POSITION IN A NON-BRAINLAB HEADHOLDER. 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. DRAPED THE PATIENT AND PLACED A STERILE NON-BRAINLAB TRANSPARENT DRAPE OVER THE UNSTERILE REFERENCE ARRAY, AND ATTACHED THE BRAINLAB FRAMELESS BIOPSY SYSTEM. PERFORMED THE CRANIOTOMY. ALIGNED THE FRAMELESS BIOPSY SYSTEM OVER THE TUMOR'S LOCATION WITH THE AID OF NAVIGATION (NO TRAJECTORY WAS PRE-PLANNED) AND USED THE PAJUNK BIOPSY NEEDLE TO COLLECT A TISSUE SAMPLE FROM THE TUMOR. SENT THE TISSUE SAMPLE TO PATHOLOGY, WHICH RETURNED AS NON-PATHOLOGICAL. COLLECTED A SECOND SAMP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10387219 ↗
• InjuryJun 26, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR RESECTION OF AN ARTERIOVENOUS MALFORMATION (AVM) LOCATED NEAR THE LEFT ROLANDIC FISSURE, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. A PREOPERATIVE MRI SCAN WAS ACQUIRED FIVE 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. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE MRI USING THE Z-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. PLANNED THE CRANIOTOMY WITH THE AID OF NAVIGATION IN THE UNSTERILE ENVIRONMENT. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY, DRAPED THE PATIENT, AND ATTACHED HE STERILE REFERENCE ARRAY. PERFORMED THE CRANIOTOMY (7 X 7 CM) AND REMOVED THE BONE FLAP. DETECTED A DEVIATION IN THE DISPLAY OF NAVIGATION COMPARED TO THE PATIENT'S ANATOMY: THE CRANIOTOMY WAS NOT LOCATED OVER THE AVM AS INTENDED, DEVIATING BY APPROXIMATELY 40MM. THERE WAS INTENSIVE BLEEDING FROM THE CRANIOTOMY DUE TO ITS LOCATION CLOSER TO

  Patient problems: Blood Loss; Dysphasia; Paralysis

  MAUDE report 10200422 ↗
• InjuryFeb 26, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  WHAT IS THE ISSUE? A CRANIAL SURGERY FOR RESECTION OF A LEFT OCCIPITAL TUMOR APPROXIMATELY 15.3MM IN DIAMETER AND ABOUT 1CM DEEP, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL (B)(4) A PREOPERATIVE MRI SCAN WAS ACQUIRED ONE DAY PRIOR TO THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN PRONE POSITION IN A NON-BRAINLAB HEADHOLDER. PERFORMED THE 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 WAS UNSATISFIED WITH HIS FIRST FEW ATTEMPTS AT REGISTRATION, BUT FINALLY ACHIEVED A REGISTRATION THAT HE DEEMED SUBOPTIMAL, BUT SUFFICIENT FOR THE SURGERY, 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. PLANNED THE INCISION AND CRANIOTOMY WITH THE STERILE POINTER. RESECTED THE TUMOR USING THE AID OF NAVIGATION, AND OBSERVED THE RESECTED TISSUE APPEARED ABNORMAL, WHI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9757219 ↗
• InjuryFeb 21, 2020Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR AN OPEN BIOPSY AND REMOVAL OF A TUMOR LOCATED IN THE PATIENT'S RIGHT TEMPORAL LOBE WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. TWO PREOPERATIVE MRI SCANS WERE ACQUIRED SIX DAYS BEFORE THE SURGERY TO BE USED WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE POSITION IN A NON-BRAINLAB HEADHOLDER. PERFORMED AN INTRAOPERATIVE CT SCAN AND VERIFIED AND ACCEPTED THE AUTOMATIC REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION (TO THE INTRA-OPERATIVE CT SCAN IMPORTED INTO AND USED BY THE NAVIGATION). USED THE BRAINLAB PLANNING SOFTWARE (BRAINLAB ELEMENTS) TO PERFORM AN IMAGE FUSION OF THE INTRAOPERATIVE CT TO THE PREOPERATIVE MRI IMAGE DATASETS, AND REVIEWED AND ACCEPTED THE FUSION OF THE DATASETS TO PROCEED. TURNED THE OR TABLE 180 DEGREES, PLANNED THE CRANIOTOMY USING THE NAVIGATED BRAINLAB POINTER, REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY, AND PREPPED AND DRAPED THE PATIENT FOR SURGERY. ATTACHED A STERILE REFERENCE ARRAY. PERFORMED THE CRANIOTOMY (APPROXIMATELY 4X4CM) AND OPENED THE DURA. DETECTED A DEVIATION OF THE DISPLAY OF NAVIGATION WHEN COMPARED TO THE PATIENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9741745 ↗
• InjurySep 20, 2019Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR RESECTION OF A RIGHT POSTERIOR TUMOR WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. A PREOPERATIVE MRI SCAN WAS ACQUIRED ON (B)(6) 2019, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE POSITION IN A NON-BRAINLAB HEADHOLDER. RE-POSITIONED (RE-PINNED) THE PATIENT'S HEAD IN THE NON-BRAINLAB HEADHOLDER MULTIPLE TIMES. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE MRI ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED ACCURACY OF THE REGISTRATION AND DETERMINED IT NOT GOOD ENOUGH FOR THE PROCEDURE. REPEATED PATIENT REGISTRATION ON THE SAME MRI SCAN, VERIFIED THE ACCURACY OF THE REGISTRATION, JUDGED IT TO BE GOOD, AND ACCEPTED THE REGISTRATION TO PROCEED. PLANNED THE LOCATION OF THE CRANIOTOMY USING THE AID OF NAVIGATION. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT. ATTACHED A STERILE REFERENCE ARRAY, AND RE-VERIFIED NAVIGATION ACCURACY WITH THE STERILE POINTER, JUDGING IT TO BE GOOD. PERFORMED THE CRANIOTOMY. REMOVED THE BONE FLAP, VERIFIED ACCURACY, AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9098397 ↗
• InjuryJul 1, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  WHAT IS THE ISSUE? A CRANIAL SURGERY FOR BIOPSY (DIAGNOSTIC SAMPLE ONLY) OF A BRAIN TUMOR IN THE RIGHT SIDE OF THE BRAIN 7CM DEEP WITH A SIZE OF CA. 1 CM IN DIAMETER, WAS PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL NAVIGATION 3.1. PRE-OPERATIVE MRI SCANS WERE ACQUIRED ON MAY 24, 2019, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: PLANNED A TRAJECTORY ON THE PRE-OPERATIVE MRI USING THE BRAINLAB TRAJECTORY ELEMENT. POSITIONED THE PATIENT IN A SUPINE ORIENTATION ON THE OR TABLE IN A NON-BRAINLAB HEAD-HOLDER, AND THE BRAINLAB REFERENCE ARRAY WAS ATTACHED. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI USING THE SOFTOUCH AND Z-TOUCH ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, AND VERIFIED THE ACCURACY OF THE REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED. ALIGNED THE VARIOGUIDE TO THE PREPLANNED TRAJECTORY AND INSERTED A 3RD PARTY DRILL GUIDE TO THE VARIOGUIDE TO CREATE THE BURR HOLE. THE SURGEON USED THE BRAINLAB-DISTRIBUTED BIOPSY NEEDLE TO COLLECT 4-6 SAMPLES VIA 1 PASS, WHICH WERE SENT TO PATHOLOGY FOR DIAGNOSIS. DETERMINED VIA THE RESULTS OF THE PAT

  Patient problems: Weakness

  MAUDE report 8750608 ↗
• InjuryMay 2, 2019Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR BIOPSY (DIAGNOSTIC SAMPLE) OF BRAIN TUMOR WITH A SIZE OF CA. 3.31CM³ LOCATED 42MM DEEP IN THE TEMPORAL LOBE OF THE BRAIN, WAS PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL NAVIGATION 3.1. PRE-OPERATIVE MRI SCANS WERE ACQUIRED ONE DAY PRIOR TO THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER AND ATTACHED THE BRAINLAB NAVIGATION REFERENCE ARRAY. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE 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 BY CHECKING ANATOMICAL LANDMARKS, JUDGED IT TO BE GOOD, AND ACCEPTED THE REGISTRATION TO PROCEED. REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT. ATTACHED A STERILE NAVIGATION REFERENCE ARRAY, RE-VERIFIED NAVIGATION ACCURACY, DETERMINED THE LOCATION OF THE BURR HOLE FOR THE DESIRED APPROACH WITH NAVIGATION AND CREATED A SINGLE 15MM BURR HOLE (CRANIOTOMY). ASSEMBLED AND SETUP THE BRAINLAB FRAMELESS BIOPSY SYSTEM AND ALIGNED IT TO THE INTENDED LO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8573361 ↗
• InjuryMar 28, 2019Use 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 (DIAGNOSTIC SAMPLE) OF A LEFT PARIETAL BRAIN TUMOR LOCATED 4CM CRANIO-CAUDAL, 4.4CM ANTERO-POSTERIOR, AND 2.6CM MEDIO-LATERAL, WITH THE MOST SUPERFICIAL PART CA. 2CM DEEP IN THE BRAIN WITH A SIZE OF CA. 3X3X3CM, HAS BEEN PERFORMED WITH THE AID OF BRAINLAB NAVIGATION VERSION 3.1. A PRE-OPERATIVE MRI SCAN WAS ACQUIRED 1 DAY PRIOR TO THE SURGERY, TO USE WITH NAVIGATION. A TRAJECTORY WAS PLANNED ON THE MRI SCAN USING BRAINLAB ELEMENTS. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION WITH THE HEAD TILTED TO THE RIGHT IN A NON-BRAINLAB HEAD HOLDER AND ATTACHED THE BRAINLAB 4-SPHERE STANDARD CRANIAL REFERENCE ARRAY 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 AT 5 OF THE 6 FIDUCIAL MARKERS TO BE VERY GOOD, WITH SLIGHTLY LESS ACCURACY AT 1 FIDUCIAL MARKER, BUT DEEMED ACCEPTABLE OVERALL. DRAPED THE UNSTERILE NAVIGATION REFERENCE ARRAY W

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8461634 ↗
• InjuryNov 15, 2018Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR TUMOR RESECTION OF A LESION WAS PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 3.1. ACCORDING TO THE SURGEON'S PLANNING THE TUMOR LOCATION WAS SUPERFICIAL AND CLOSE TO THE MIDLINE WITH A SIZE OF 1,8 CCM. A PRE-OPERATIVE MRI SCAN FOR USE WITH BRAINLAB NAVIGATION WAS ACQUIRED ONE DAY PRIOR TO THE DAY OF SURGERY. 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 Z-TOUCH) TO MATCH THE VIRTUAL DISPLAY OF PREOPERATIVE MRI SCAN TO THE CURRENT PATIENT ANATOMY AND VERIFIED THE ACCURACY OF REGISTRATION WITH A SATISFYING RESULT. PLANNED THE CRANIOTOMY WITH THE AID OF NAVIGATION. DRAPED THE PATIENT, INCLUDING EXCHANGING THE NAVIGATION REFERENCE ARRAY FROM UNSTERILE TO STERILE. PERFORMED THE CRANIOTOMY. VERIFIED THE LOCATION OF THE CRANIOTOMY AND NOTICED A DEVIATION OF THE NAVIGATION INFORMATION COMPARED TO THE PATIENT ANATOMY OF ABOUT 10 MM LATERAL TO THE MIDLINE. EXTENDED THE CRANIOTOMY TO BE ABLE TO VIEW AND ACCESS THE TUMOR AND SUCC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8072963 ↗
• MalfunctionNov 7, 2018Use of Device Problem; Use of Device Problem

  AN OPEN CRANIAL SURGERY FOR BIOPSY AND RESECTION OF A SMALL TUMOR NODULE WITH A DIAMETER OF CA. 17MM, LOCATED IN THE LEFT FRONTAL PARS OPERCULARIS, CA. 20MM DEEP IN THE BRAIN, WAS INTENDED TO BE PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 3.1. A PRE-OPERATIVE MRI WAS ACQUIRED 3 DAYS BEFORE THE SURGERY TO USE WITH NAVIGATION. A TRAJECTORY WAS PLANNED SINCE THE NODULE WAS LOCATED IN THE LANGUAGE AREA. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN LATERAL 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 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 ACCURACY ACHIEVED TO BE GOOD AND ACCEPTABLE FOR USE FOR THIS CASE. DRAPED THE PATIENT, AND EXCHANGED THE NAVIGATION REFERENCE ARRAY TO A STERILE ARRAY. USED A PRIOR EXISTING BONE FLAP FOR THE CRANIOTOMY, WITH STANDARD SIZE OF 5MM. RESECTED TISSUE, AND SENT SAMPLES FROM THE RESECTED TISSUE TO PATHOLOGY. CONCLUDED THE SURGERY AND CLOSED THE PATIENT. A POST-OP C

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8045255 ↗
• InjuryOct 31, 2018Use 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 CATHETER PLACEMENT FOR CONVECTION-ENHANCED DRUG DELIVERY (CED) HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM 3.1.3 (ON (B)(6) 2018). TARGET WAS A GLIOBLASTOMA BRAIN TUMOR, WITH DIAMETER APPROX. 27 MM, LOCATED IN THE RIGHT TEMPORAL / OCCIPITAL LOBES, APPROX. 6 CM FROM THE SURFACE. SEVERAL PRE-OPERATIVE CT/MRI SCANS WERE ACQUIRED, INCLUDING AN MRI SCAN ACQUIRED ON THE DAY OF SURGERY, TO USE WITH NAVIGATION. TWO TRAJECTORIES WERE PLANNED FOR THE PROCEDURE USING IPLAN FLOW. PLACEMENT OF TWO CATHETERS WAS INTENDED. DURING THE PROCEDURE THE SURGEON/RESIDENT: POSITIONED THE PATIENT IN A LATERAL ORIENTATION AND ATTACHED THE 4 SPHERE STANDARD CRANIAL REFERENCE ARRAY FOR NAVIGATION; REPLANNED THE TRAJECTORIES USING BRAINLAB CRANIAL NAVIGATION SYSTEM; PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OPERATIVE MRI 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; REPLANNED THE ENTRY POINTS OF THE PLANNED TRAJECTORIES USING AID OF NAVIGATION; DRAPED THE PATIENT AND EXCHANGED THE UNSTERILE REFERENCE ARRAY FOR A STERILE ONE; VERIFIED A

  Patient problems: Hemorrhage, Subarachnoid

  MAUDE report 8022881 ↗
• InjuryOct 2, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  AN OPEN CRANIOTOMY FOR TUMOR RESECTION WAS PLANNED TO BE PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 3.1.1 (ON (B)(6) 2018). THE TUMOR DIMENSION WAS ABOUT 20 MM IN DIAMETER, IT WAS LOCATED IN THE FRONTAL/TEMPORAL LOBE, ABOUT 74 MM FROM THE TOP OF THE HEAD AND 35 MM FROM THE SURFACE LATERALLY. A PRE-OPERATIVE MRI SCAN WAS ACQUIRED 4 DAYS BEFORE THE SURGERY, FOR USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEONS: POSITIONED THE PATIENT IN LATERAL ORIENTATION AND ATTACHED THE 4 SPHERE STANDARD CRANIAL REFERENCE ARRAY FOR NAVIGATION. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OPERATIVE MRI SCAN (TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY), VERIFIED ACCURACY OF THE REGISTRATION AND DETERMINED IT NOT GOOD ENOUGH FOR THIS PROCEDURE. REPEATED PATIENT REGISTRATION ON THE SAME MRI SCAN, VERIFIED ACCURACY OF THE REGISTRATION AND DETERMINED IT LESS THAN OPTIMAL BUT GOOD ENOUGH FOR THIS PROCEDURE. PLANNED THE CRANIOTOMY USING AID OF NAVIGATION. DRAPED THE PATIENT (DID NOT VERIFY ACCURACY DIRECTLY AFTER DRAPING). PERFORMED THE CRANIOTOMY (ABOUT 10 CM IN DIAMETER), REMOVED THE BONE FLAP AND OPENED THE DURA ON THE PLANNED POSIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7925087 ↗
• MalfunctionSep 28, 2018Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A BIOPSY (FOR RETRIEVAL OF A DIAGNOSTIC SAMPLE) OF A LESION WITH A SIZE OF CA. 8.6CCM, LOCATED CA. 50MM FROM THE BONE SURFACE IN THE BRAIN BETWEEN THE TEMPORAL AND PARIETAL LOBES, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 3.1. ONE PASS FOR THREE TO FOUR SAMPLES 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 LATERAL 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, 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. 15MM. EQUIPPED A NON-BRAINLAB BIOPSY NEEDLE WITH AN ARRAY, AND CALIBRATED THE NEEDLE TO THE NAVIGATION. THE FRAMELESS BIOPSY SYSTEM WAS USED AS INSTRUMENT HOLDE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7918347 ↗
• MalfunctionSep 17, 2018Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR CATHETER PLACEMENT FOR CONVECTION-ENHANCED DRUG DELIVERY (CED) TO A TUMOR OF SEVERAL CM IN PONS OF BRAINSTEM (DIPG), HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 3.1. SEVERAL PRE-OPERATIVE MRI SCANS WERE ACQUIRED, INCLUDING MRI SCANS 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 CLAMPED INTO A (NON-BRAINLAB) HEAD HOLDER, ATTACHED THE BRAINLAB 4 SPHERE DRAPELINK 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 NOT PERFECT, BUT GOOD AND ACCEPTABLE FOR USE FOR THIS CASE. USED THE BRAINLAB POINTER TO MARK OUT THE ENTRY POINT FOR THE CATHETER. DRAPED THE PATIENT, INCLUDING EXCHANGING THE DRAPELINK NAVIGATION REFERENCE ARRAY FROM UNSTERILE TO STERILE, AND RE-VERIFIED THE ACCUR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7880500 ↗
• InjurySep 6, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  A BIOPSY (INITIAL CASE) AND AN OPEN CRANIOTOMY (REVISION SURGERY) HAVE BEEN PERFORMED ON (B)(6) 2018 WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM 3.1. DURING THE PROCEDURE THE SURGEON: PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OPERATIVE IMAGE SCAN (TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY) AND VERIFIED THE ACCURACY OF REGISTRATION WITH A SATISFYING RESULT. TOOK THE BIOPSY WITH AID OF NAVIGATION. PERFORMED A POST-OPERATIVE IMAGE SCAN AND REALIZED THAT THE BIOPSY WAS NOT TAKEN IN THE INTENDED LOCATION (DEVIATION OF APPROX. 1 CM). DECIDED TO PERFORM A REVISION SURGERY. PERFORMED AN OPEN CRANIOTOMY WITH AID OF NAVIGATION ON (B)(6) 2018. WAS NOT ABLE TO REMOVE THE LESION IN THIS SURGERY. THE HOSPITAL DID NOT REPORT ANY NEGATIVE CLINICAL EFFECTS FOR THIS SPECIFIC PATIENT DUE TO THIS ISSUE NOR ANY FURTHER REMEDIAL ACTIONS (BESIDES REVISION SURGERY) THAT WOULD HAVE BEEN NECESSARY. BASED ON THE INFORMATION RECEIVED, THE SYSTEM HAS BEEN USED FOR OTHER SURGERIES/PATIENTS SINCE, WITHOUT ANY ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7849580 ↗
• InjuryAug 14, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A TUMOR RESECTION WAS PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 3.1.0 (ON (B)(6) 2018). THE TUMOR DIAMETER WAS ABOUT 8 MM, IT WAS LOCATED ABOUT 18 MM FROM THE SURFACE, IN THE FRONTAL/PARIETAL LOBE. PRE-OPERATIVE SCANS ACQUIRED: CT SCAN (2 DAYS PRIOR SURGERY, USED FOR REGISTRATION), MRI SCAN (16 DAYS PRIOR SURGERY, USED FOR NAVIGATION). DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE ORIENTATION, ATTACHED VARIO ARM AND 4 SPHERE STANDARD CRANIAL REFERENCE ARRAY FOR NAVIGATION. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OPERATIVE CT SCAN (TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY). PERFORMED RE-REGISTRATION ON THE PRE-OPERATIVE CT SCAN, SINCE PATIENT HAD COUGHED AND POTENTIALLY MOVED IN THE SKULL PINS. VERIFIED ACCURACY OF THE REGISTRATION AT MULTIPLE ANATOMICAL POSITIONS AND DETERMINED IT TO BE GOOD. MARKED INCISION. DRAPED THE PATIENT, AND EXCHANGED THE UNSTERILE REFERENCE ARRAY FOR A STERILE ONE. VERIFIED REGISTRATION ACCURACY AND PROCEEDED. PERFORMED CRANIOTOMY, OPENED DURA, AND PROCEEDED TO TUMOR LOCATION, BUT WAS NOT ABLE TO LOCATE THE DEFINED TUMOR. BEGAN TO RESECT WHERE NAVIGATION INDICATE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7780711 ↗
• InjuryJul 4, 2018Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  AN OPEN TUMOR RESECTION WAS PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 3.1.0 (ON (B)(6) 2018). THE TUMOR DIMENSIONS WERE 30 X 25 X 27.5 MM, IT WAS LOCATED ABOUT 25 MM FROM THE SURFACE, IN THE LEFT CEREBELLUM. A PRE-OPERATIVE MRI SCAN WAS ACQUIRED 7 DAYS BEFORE THE SURGERY, FOR USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN PRONE ORIENTATION AND ATTACHED THE 4 SPHERE STANDARD CRANIAL REFERENCE ARRAY FOR NAVIGATION PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OPERATIVE MRI SCAN (TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY) VERIFIED ACCURACY OF THE REGISTRATION AND DETERMINED IT TO BE VERY GOOD; REGISTRATION ACCURACY WAS FURTHER CONFIRMED BY AN ADDITIONAL SURGEON DRAPED THE PATIENT, VERIFIED REGISTRATION ACCURACY AND AGAIN DETERMINED IT TO BE VERY GOOD PERFORMED INCISION AND MUSCLE DISSECTION, AND SUSPECTED A POTENTIAL DEVIATION OF NAVIGATION DISPLAY AND ACTUAL PATIENT ANATOMY OF A FEW MM ALREADY AT THIS STEP PERFORMED CRANIOTOMY (25 X 25 MM) AND OPENED DURA WITH AID OF NAVIGATION PERFORMED A MEDIAL EXTENSION OF THE DURAL OPENING DUE TO THE POTENTIAL DEVIATION (CRANIOTOMY DID NOT HAVE TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7661835 ↗
• InjuryJun 27, 2018Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  A CRANIOTOMY FOR TUMOR RESECTION WAS PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 3.1.1 (ON (B)(6) 2018). THE TUMOR DIMENSIONS WERE 25 MM X 17 MM, IT WAS LOCATED ABOUT 18 MM FROM THE SURFACE, AT THE BORDER BETWEEN FRONTAL AND PARIETAL LOBES. A PRE-OPERATIVE MR SCAN WAS ACQUIRED 6 DAYS BEFORE THE SURGERY, FOR USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE ORIENTATION AND ATTACHED THE 4 SPHERE STANDARD CRANIAL REFERENCE ARRAY FOR NAVIGATION. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OPERATIVE MR SCAN (TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY), VERIFIED ACCURACY OF THE REGISTRATION AND DETERMINED IT NOT GOOD ENOUGH FOR THIS PROCEDURE. REPEATED PATIENT REGISTRATION ON THE SAME MR SCAN, VERIFIED ACCURACY OF THE REGISTRATION AND DETERMINED IT ACCEPTABLE FOR THIS PROCEDURE. PLANNED CRANIOTOMY USING AID OF NAVIGATION. DRAPED THE PATIENT, VERIFIED ACCURACY AROUND THE REGION OF INTEREST. PERFORMED CRANIOTOMY (5 CM IN DIAMETER), REMOVED BONE FLAP AND OPENED DURA ON THE PLANNED POSITION. DETERMINED RESECTION STARTING POINT USING AID OF NAVIGATION AND BEGAN RESECTING BRAIN TISSUE WHERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7640921 ↗
• InjuryMay 18, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR AN OPEN BIOPSY AND TUMOR RESECTION OF A LESION WITH A SIZE OF ABOUT 4,4 CCM, LOCATED CA. 40 MM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 3.1. A PRE-OPERATIVE MRI SCAN WAS ACQUIRED 7 DAYS BEFORE THE SURGERY, FOR USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION. - PERFORMED THE INITIAL PATIENT REGISTRATION (SURFACE MATCHING REGISTRATION WITH BRAINLAB Z-TOUCH) TO MATCH THE VIRTUAL DISPLAY OF PREOPERATIVE MRI 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, AND RE-VERIFIED THE ACCURACY. - PERFORMED AN OPEN BIOPSY (FOR AN INTRASURGICAL FROZEN SECTION ANALYSIS) AND RESECTED TISSUE WITH THE AID OF NAVIGATION AND VISUAL INSPECTION. - CLOSED THE PATIENT. DIRECTLY AFTER THE SURGERY THE INTRASURGICAL FROZEN SECTION ANALYSIS REVEALED THAT THE RESECTED TISSUE WAS NO TUMOR TISSUE. A CT SCAN WAS PERFORMED IMMEDIATELY AND SHOWED THAT THE BIOPSY AND RESECTION HAD NOT BEEN PERFORMED IN THE INTENDED LOCATION BUT ABOUT 15 MM POST

  Patient problems: Paresis; Visual Impairment

  MAUDE report 7524922 ↗
• MalfunctionMay 9, 2018Use 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, LOCATED SUPERFICIAL UNDER THE DURA RIGHT PARIETAL WITH A SIZE OF CA. 1.2 CCM, WAS INTENDED TO BE PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 3.1. A PRE-OPERATIVE MRI WAS ACQUIRED BEFORE THE SURGERY ON THE SAME DAY TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE ORIENTATION RIGHT SIDE UP 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 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 ACCURACY ACHIEVED TO BE ACCEPTABLE FOR USE FOR THIS CASE. DRAPED THE PATIENT, AND NAVIGATION REFERENCE ARRAY WAS EXCHANGED TO A STERILE ARRAY. PERFORMED THE CRANIOTOMY - SMALL BONE FLAP OF CA. 1-2 CM DIAMETER - WITH AID OF NAVIGATION. RECOGNIZED THAT THE BONE FLAP WAS NOT CENTERED OVER THE TUMOR AS DESIRED, BUT DEVIATED BY CA. 2 CM. DECIDED TO CONTINUE THIS SURGERY WITHOUT FURTHER USE OF THE AID OF NAVIGATION. EXTENDED THE EXISTING CRANIOTOMY BY CA. 1 CM TO B

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7497826 ↗
• InjuryApr 11, 2018Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR RESECTION OF A TUMOR (WITH A SIZE OF APPROXIMATELY 0.1 CC IN VOLUME AND 4 MM DIAMETER) WAS PLANNED TO BE PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 3.1. DURING THE PROCEDURE THE SURGEON: PERFORMED THE INITIAL PATIENT REGISTRATION (WITH SURFACE MATCHING) TO MATCH THE VIRTUAL DISPLAY OF PREOPERATIVE CT SCAN TO THE CURRENT PATIENT ANATOMY AND VERIFIED THE ACCURACY OF REGISTRATION WITH A SATISFYING RESULT. PERFORMED A CRANIOTOMY, OPENED THE DURA, DISSECTED TISSUE ALONG THE PATH DOWN TO THE ASSUMED TUMOR LOCATION AND RESECTED TISSUE, ALL WITH THE AID OF THE BRAINLAB NAVIGATION DEVICE. ONE DAY AFTER THE SURGERY A POST-OPERATIVE SCAN WAS PERFORMED TO CONFIRM THE EFFECTIVENESS OF THE PROCEDURE. THE SCAN SHOWED THAT THE ENTIRE TUMOR LOCATION WAS MISSED AND THERE WAS NO RESECTION IN THE INTENDED REGION. ALSO PATHOLOGY CONFIRMED THAT THE SAMPLE TAKEN DURING THE CASE WAS NOT PATHOLOGICAL. THE PATIENT HAD AN ADDITIONAL SURGERY WITH THE AID OF BRAINLAB NAVIGATION, IN WHICH THE TUMOR WAS SUCCESSFULLY RESECTED. ACCORDING TO THE HOSPITAL THERE ARE NO NEGATIVE CLINICAL EFFECTS FOR THIS PATIENT DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7420437 ↗

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