CranialRecalls & reported problems across all models

We found 2 models of Cranial by Brainlab SE in the FDA's device registry (GUDID). Together they are named in 64 adverse event reports in the FDA's MAUDE database, received between Oct 21, 2016 and Sep 30, 2021 — classified as 33 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (62 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Cranial problems

Cranial models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cranial 3.1

  Neurological Stereotaxic Instrument
  37 reports
• Cranial 2.1

  Neurological Stereotaxic Instrument
  27 reports

Recent Cranial adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗

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