Cranial Navigation System Navigation 4.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04056481141356), received between Jun 11, 2021 and Feb 28, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (14 reports).

2 other recalls cover devices cleared under the same FDA submission (K092467, K192703); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY, FOR A VENTRICULOPERITONEAL (VP) SHUNT PLACEMENT, WAS PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL/ENT 3.1. DURING PLACEMENT OF THE PROXIMAL SHUNT CATHETER, THE SURGEON REQUIRED MULTIPLE PASSES TO PLACE THE SHUNT IN THE TARGET VENTRICLE WITH THE AID OF NAVIGATION. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH THE INTENDED SHUNT PLACEMENT CORRECT AT THE END OF THE SURGERY. THERE WAS NO ACTUAL HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE ADDITIONAL ATTEMPTS NEEDED TO CANNULATE THE LATERAL VENTRICLE, DESPITE A DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THE ADDITIONAL ATTEMPTS. THERE WAS NO OTHER HARM OR NEGATIVE EFFECT TO THE PATIENT REPORTED, NEITHER DUE TO THE PROLONGED ANESTHESIA OF CA. 5 MINUTES, AND THERE WERE NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED. HOSPITALIZATION OF THE PATIENT WAS NOT PROLONGED DUE TO THIS ISSUE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21496574 ↗
• InjuryJul 18, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A BIOPSY OF A CA. 3.84 CCM LESION LOCATED IN THE RIGHT CEREBELLUM HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM SOFTWARE VERSION 4.0. 1 BIOPSY PASS WITH 4-6 SAMPLES WAS INTENDED AND A TRAJECTORY WAS PLANNED ON THE SURGERY DAY USING A PRE-OPERATIVE MRI T1 SCAN OF THE PATIENT ACQUIRED 8 DAYS BEFORE THE SURGERY. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT'S HEAD IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER WITH THE HEAD TURNED TO THE PATIENT'S LEFT AND ATTACHED THE 4-SPHERE NAVIGATION REFERENCE ARRAY TO THE REFERENCE ARM. - PERFORMED THE PATIENT REGISTRATION ON A PREOPERATIVE MRI SCAN USING THE BRAINLAB SOFTOUCH TO ACQUIRE POINTS ON THE PATIENT'S SKIN THAT MATCHED THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT'S ANATOMY. - VERIFIED THE ACCURACY OF THE REGISTRATION, USING THE SOFTOUCH ON MULTIPLE ANATOMICAL LANDMARKS ON THE PATIENT'S HEAD AND DEEMED IT ACCEPTABLE TO PROCEED. - PREPARED, DRAPED THE PATIENT AND SWITCHED OUT THE NON-STERILE 4-SPHERE NAVIGATION REFERENCE ARRAY FOR A STERILE ONE. - ATTACHED THE BRAINLAB VARIOGUIDE AND ALIGNED IT TO THE PLANNED TRAJECTORY. - VERIFIED THE TRAJECTORY USING THE VARI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19772051 ↗
• InjuryMay 23, 2024Use of Device Problem; Use of Device Problem

  A PLANNED OPEN CRANIOTOMY SURGERY FOR A BRAIN TUMOR BIOPSY, WITH THE TARGET LOCATED IN THE LEFT FRONTAL LOBE CA. 16MM DEEP WITH A SIZE OF CA. 12MM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 4.0. PRE-OPERATIVE MRI SCANS WERE ACQUIRED CA. 3 AND A HALF WEEKS BEFORE THE SURGERY TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION WITH THE HEAD TURNED TO THE RIGHT IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. USED THE SOFTOUCH FOR SURFACE MATCHING TO ACQUIRE SKIN POINTS ON THE PATIENT'S HEAD TO REGISTER THE CURRENT PATIENT ANATOMY TO THE SCAN DISPLAYED BY THE NAVIGATION. VERIFIED THE REGISTRATION TO NAVIGATION AS PROMPTED, AND DETECTED THAT THE NAVIGATION ACCURACY ACHIEVED WAS INSUFFICIENT FOR THE INTENDED PROCEDURE, AND PERFORMED FURTHER REGISTRATION ATTEMPTS. CHOSE TO USE A REGISTRATION TO NAVIGATION THAT THE USER AT VERIFICATION ASSESSED WITH A LESS THAN OPTIMAL ACCURACY, BUT GOOD ENOUGH FOR THIS PROCEDURE, TO PROCEED. DRAPED THE PATIENT AND EXCHANGED THE NAVIGATION REFERENCE ARRAY TO A STERILE ONE. PLANNED THE LOCATION OF THE INCISION AND C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379754 ↗
• InjuryApr 5, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A TUMOUR RESECTION, WAS PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SOFTWARE VERSION 4.0. AS PER THE HOSPITAL, A POST-OPERATIVE MRI SCAN OF THE PATIENT SHOWED THAT THE RESECTION WAS PERFORMED AT A DIFFERENT LOCATION THAN WAS INTENDED BY THE SURGEON AND THE TUMOUR WAS MISSED. A REVISION SURGERY WAS PLANNED AND PERFOMED, CA. TWO DAYS AFTER THE INITIAL SURGERY, TO RESECT THE TUMOUR. THE OUTCOME OF THE REVISION SURGERY, PERFORMED WITH THE AID OF BRAINLAB NAVIGATION, WAS REPORTEDLY SUCCESSFUL AS INTENDED. FURTHER DETAILS OF THE EFFECTS ON THE PATIENT COULD NOT YET BE RETRIEVED FROM THE HOSPITAL, BRAINLAB CONTINUES TO FOLLOW UP WITH THE USER FACILITY.

  Patient problems: Dysphasia; Insufficient Information; Loss of Vision

  MAUDE report 19049135 ↗
• InjuryNov 27, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR ABLATION OF A TUMOR, ABOUT 5 CM IN SIZE AND LOCATED RIGHT TEMPORAL AT A DEPTH OF APPROX. 180 MM IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAV. SW CRANIAL 4.0.0 (AND THE BRAINLAB NAV. SW CRANIAL 3.1.5 WITH VARIOGUIDE) (ON (B)(6) 2023). PLACEMENT OF ONE LASER FIBER WAS INTENDED, WITH A BIOPSY OF THE TUMOR BEFOREHAND WITH THE SAME PATH. PRE-OPERATIVE MRI SCANS WERE ACQUIRED FIVE DAYS BEFORE THE SURGERY, AND A TRAJECTORY WAS PLANNED. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A LATERAL ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, WITH THE HEAD TURNED TO THE PATIENT'S LEFT, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. - TURNED THE PATIENT 90 DEGREES ACCORDING TO WHERE THE CT SCANNER WAS POSITIONED, ACQUIRED AN INTRA-OPERATIVE CT SCAN OF THE PATIENT'S REGION OF INTEREST WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, VERIFIED REGISTRATION ACCURACY, AND ACCEPTED THE ACCURACY TO PROCEED, VERIFIED AND CONFIRMED REGISTRATION ACCURACY ALSO ON THE FUSED PRE-OPERATIVELY ACQUIRED MRI SCAN. - TURNED THE PATIENT ANOTHER 90 DEGREES SO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208179 ↗
• InjuryNov 10, 2023Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY ON FRONTAL LOBE, RIGHT SIDE, FOR TUMOR RESECTION WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL NAVIGATION APP 4.0. A PRE-OPERATIVE CT AND MR SCAN ACQUIRED 10 DAYS BEFORE SURGERY WAS USED TO REFERENCE THE NAVIGATION DISPLAY TO. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN SUPINE POSITION IN A NON-BRAINLAB HEAD HOLDER, WITH THE HEAD TURNED TO THE PATIENT'S RIGHT, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. - PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OPERATIVE CT SCAN BY ACQUIRING SURFACE MATCHING REGISTRATION POINTS WITH THE BRAINLAB SOFTOUCH REGISTRATION POINTER ON THE PATIENT HEAD'S SKIN, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - VERIFIED THE REGISTRATION AND DETERMINED THE ACCURACY AS NOT SUFFICIENT TO PROCEED. - PERFORMED ANOTHER PATIENT REGISTRATION USING THE BRAINLAB SOFTOUCH, BUT STILL DETERMINED THE ACCURACY AS NOT SUFFICIENT. - PERFORMED AGAIN A PATIENT REGISTRATION USING THE BRAINLAB SOFTOUCH AND ADDITIONALLY THE BRAINLAB Z-TOUCH, VERIFIED THE REGISTRATION AND ACCEPTED THE ACCURACY TO PROCEED. - LOCALIZED THE INCISION WITH THE AID OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18109993 ↗
• InjuryOct 27, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR A TUMOR LOCATED RIGHT PARIETAL AT A DEPTH OF APPROX. 42 MM IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 4.0.0 (AND THE BRAINLAB NAV. SW CRANIAL 3.1.5 WITH VARIOGUIDE) (ON (B)(6) 2023). PLACEMENT OF ONE LASER FIBER WAS INTENDED, WITH A BIOPSY OF THE TUMOR BEFOREHAND WITH THE SAME PATH. A PRE-OPERATIVE MRI SCAN WAS ACQUIRED TWO DAYS BEFORE THE SURGERY, AND A TRAJECTORY WAS PLANNED. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A LATERAL ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, WITH THE HEAD TURNED TO THE PATIENT'S LEFT, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER - PERFORMED THE PATIENT REGISTRATION ON THE PRE-OPERATIVE MRI SCAN BY ACQUIRING SURFACE MATCHING REGISTRATION POINTS WITH THE SOFTOUCH REGISTRATION POINTER ON THE PATIENT HEAD'S SKIN, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED THE REGISTRATION TO NAVIGATION, AND ACCEPTED THE ACCURACY TO PROCEED - LOCATED THE PLANNED TRAJECTORY WITH THE SOFTOUCH AND MARKED THE ENTRY POINT ON THE PATIENT'S SKIN, DRAPED THE PATIENT, AND EXCHANGED THE UNSTERILE NAV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023539 ↗
• InjuryOct 25, 2023Use 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 LESION LOCATED RIGHT PARIETAL AT A DEPTH OF APPROX. 19.2 MM IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAV. SW CRANIAL 4.0.0 (AND THE BRAINLAB NAV. SW CRANIAL 3.1.5 WITH VARIOGUIDE) (ON (B)(6) 2023). A PRE-OPERATIVE MRI WAS ACQUIRED AT THE DAY OF SURGERY FOR USE WITH NAVIGATION, AND A TRAJECTORY WAS PLANNED. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A LATERAL ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, WITH THE HEAD TURNED TO THE PATIENT'S LEFT, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER - PERFORMED THE PATIENT REGISTRATION ON THE PRE-OPERATIVE MRI SCAN BY ACQUIRING SURFACE MATCHING REGISTRATION POINTS WITH THE BRAINLAB SOFTOUCH AND Z-TOUCH REGISTRATION POINTER ON THE PATIENT HEAD'S SKIN, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED THE REGISTRATION TO NAVIGATION, AND ACCEPTED THE ACCURACY TO PROCEED - PERFORMED A LUMBAR PUNCTURE - LOCATED THE PLANNED TRAJECTORY WITH THE SOFTOUCH AND MARKED THE ENTRY POINT ON THE PATIENT'S SKIN, DRAPED THE PATIENT, AND EXCHANGED THE UNSTERILE NAVIGATION REFERENCE FOR A STERILE ONE - ATTACHED THE BRAINLAB VARI

  Patient problems: Intracranial Hemorrhage

  MAUDE report 18002099 ↗
• InjuryOct 9, 2023Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR RIGHT VENTRICULOSTOMY (PLACEMENT OF AN EXTERNAL VENTRICULAR DRAIN, AT A DEPTH OF APPROX. 63 MM) AND LEFT CRANIOTOMY FOR TUMOR RESECTION (TUMOR WITH SIZE OF APPROX. 2.91 CM3 AT A DEPTH OF APPROX. 50 MM), HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAV. SW CRANIAL 3.1.5 AND 4.0.0 (ON (B)(6), 2023). A PRE-OPERATIVE MRI SCAN (WITH PATIENT IN SUPINE POSITION) WAS ACQUIRED THE DAY BEFORE THE SURGERY, TO USE WITH NAVIGATION. A TRAJECTORY FOR THE DRAINAGE TUBE WAS PRE-PLANNED PRIOR TO THE PROCEDURE ON THE SURGERY DAY. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A PRONE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION (4-SPHERE ARRAY ON VARIO ARM) TO THE HEAD HOLDER PERFORMED THE PATIENT REGISTRATION ON THE PRE-OPERATIVE MRI BY ACQUIRING SURFACE MATCHING REGISTRATION POINTS WITH THE SOFTOUCH REGISTRATION POINTER ON THE PATIENT HEAD'S SKIN, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED THE REGISTRATION TO NAVIGATION, AND ACCEPTED THE ACCURACY TO PROCEED PLANNED THE VENTRICULOSTOMY AND CRANIOTOMY USING THE SOFTOUCH: MARKED THE POSITION OF THE MIDLINE, SINUSES AND TUMOR ON THE

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17893522 ↗
• InjurySep 28, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A PLANNED CRANIAL SURGERY FOR A POSTERIOR FOSSA TUMOR RESECTION HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SOFTWARE VERSION 4.0. A PRE-OPERATIVE MRI SCAN THAT WAS ACQUIRED 3 DAYS BEFORE THE SURGERY WAS USED TO REGISTER THE PATIENT ANATOMY TO THE NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN PRONE POSITION IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. USED THE SOFTOUCH FOR SURFACE MATCHING TO ACQUIRE SKIN POINTS ON THE PATIENT'S HEAD TO REGISTER THE CURRENT PATIENT ANATOMY TO THE NAVIGATION. VERIFIED THE REGISTRATION TO NAVIGATION, AND ACCEPTED THE ACCURACY TO PROCEED. PLANNED THE INCISION AND THE CRANIOTOMY (BURR HOLE) LOCATION WITH THE NAVIGATED POINTER. PERFORMED THE INCISION AND CREATED THE CRANIOTOMY IN THE SKULL. DETERMINED THAT THE TENTORIUM HAD BEEN INADVERTENTLY TRAVERSED. RECHECKED LANDMARKS WITH THE NAVIGATION AND DETERMINED A SHIFT OF THE NAVIGATION DISPLAY OF INSTRUMENT POSITIONS RELATIVE TO THE ACTUAL PATIENT ANATOMY. COMPLETED THE SURGERY WITHOUT THE AID OF NAVIGATION. SCHEDULED A FOLLOW UP SURGERY PERFORMED WITH THE AID OF A NON-BRAINLAB NAVIGATION SYSTEM. ACCORDING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15500516 ↗
• InjuryJun 21, 2022Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR A DIAGNOSTIC BIOPSY OF A BRAIN TUMOR APPROXIMATELY 5CM IN DIAMETER AND AT A DEPTH OF 7CM, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB CRANIAL NAVIGATION SOFTWARE 4.0. A PRE-OPERATIVE MRI AND CT WERE ACQUIRED NINE AND SEVEN DAYS PRIOR TO THE SURGERY, RESPECTIVELY, FOR USE WITH NAVIGATION. THE SURGEON ALSO PREOPERATIVELY PLANNED A TRAJECTORY FOR THE BIOPSY IN THE BRAINLAB SOFTWARE AND FUSED (ALIGNED) THE CT AND MRI FOR USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT SUPINE IN A NON-BRAINLAB HEADHOLDER AND ATTACHED THE NAVIGATION REFERENCE ARRAY. 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 THE REGISTRATION AND ACCEPTED IT TO PROCEED. USED THE NAVIGATED POINTER TO MARK THE ENTRY POINT ON THE PATIENT'S SKIN AND DRAPED THE PATIENT. MADE A SKIN INCISION AND CREATED THE BURR HOLE IN THE LOCATION OF THE PREVIOUSLY MARKED ENTRY POINT. CALIBRATED A NON-BRAINLAB BIOPSY NEEDLE TO THE NAVIGATION AND ACCEPTED THE ACCURACY OF THE CALIBRATION TO PROCEED. ATTACHED A NON-BRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760104 ↗
• InjuryOct 7, 2021Use 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 A RIGHT-SIDED TUMOR APPROXIMATELY 2.20CM³ IN VOLUME AND 26MM FROM THE SKIN SURFACE, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SOFTWARE CRANIAL NAVIGATION 4.0. A PRE-OPERATIVE MRI WAS ACQUIRED NINE DAYS PRIOR TO THE SURGERY FOR USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT SUPINE, ATTACHED THE NON-BRAINLAB HEADHOLDER TO THE PATIENT, AND ATTACHED THE UNSTERILE REFERENCE ARRAY TO THE HEADHOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OPERATIVE 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 IT TO PROCEED. THE SOFTWARE DISPLAYED A WARNING TO THE USER THAT THE DISTANCE BETWEEN THE REFERENCE ARRAY AND THE PATIENT WAS TOO LARGE BUT THE SURGEON OPTED TO CANCEL THE WARNING MESSAGE TO PROCEED. DRAPED THE PATIENT AND EXCHANGED THE UNSTERILE REFERENCE ARRAY WITH THE STERILE REFERENCE ARRAY. MADE THE SKIN INCISION, CREATED THE BONE FLAP, AND OPENED THE DURA AT THE PLANNED LOCATION. USED THE NAVIGATED POINTER TO AID IN LOCATING THE TUMOR, AND RESECTED TISSUE AT THE LO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591414 ↗
• InjuryJun 17, 2021Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A RESECTION OF A CEREBELLAR TUMOR HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 4.0. DURING THE SURGERY, THE PATIENT WAS POSITIONED PRONE AND THE NEUROSURGERY REGISTRAR PERFORMED THE REGISTRATION OF NAVIGATION TO THE PREOPERATIVE SCAN USING FIDUCIALS. THE REGISTRAR PLANNED THE CRANIOTOMY USING THE AID OF THE DISPLAY OF NAVIGATION, AND REMOVED THE BONE FLAP. ACCORDING TO THE SURGEON, THE LOCATION OF THE CRANIOTOMY WAS NOT IN THE INTENDED LOCATION. THE SURGEON ALLEGED THAT AN INACCURACY IN THE DISPLAY OF NAVIGATION CAUSED OR CONTRIBUTED TO THE INCORRECT LOCATION OF THE CRANIOTOMY. THE SURGEON PROCEEDED WITH THE SURGERY BY SLIGHTLY 'REFASHIONING' THE CRANIOTOMY, WITH THE SIZE OF THE CORRECTION/ENLARGEMENT DEEMED TO BE MINIMAL, ACCORDING TO THE SURGEON. THE SURGEON COMPLETED THE SURGERY SUCCESSFULLY, USING CONVENTIONAL METHODS AND WITHOUT THE USE OF NAVIGATION. ACCORDING TO THE SURGEON, THERE WAS NO ACTUAL HARM OR NEGATIVE CLINICAL EFFECT TO THE PATIENT DUE TO THIS ISSUE, ALTHOUGH THE SURGEON STATED THERE WAS AN INCREASED RISK OF HARM DUE TO THE PROXIMITY OF THE LOCATION OF THE CRANIOTOMY TO THE SINUS. THERE HAS BEEN NO REPORT OF ANY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12016353 ↗
• InjuryJun 11, 2021Use of Device Problem; Use of Device Problem

  A CRANIAL REVISION SURGERY FOR A VENTRICULOPERITONEAL (VP) SHUNT PLACEMENT CORRECTION TO DRAIN CEREBROSPINAL FLUID (CSF) FROM THE BRAIN'S RIGHT VENTRICLE, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION VERSION 4.0. A PRE-OPERATIVE CT SCAN WAS ACQUIRED THE DAY OF THE SURGERY (FOR REGISTRATION TO NAVIGATION), AND THE POST-OP CT OF THE ORIGINAL SURGERY WAS FUSED TO IT, BOTH TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEONS: POSITIONED THE PATIENT IN A SUPINE ORIENTATION WITH HEAD TURNED LEFT FIXATED IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE UNSTERILE PATIENT REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. PERFORMED THE IMAGE REGISTRATION WITH SURFACE MATCHING BY ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN SURFACE WITH THE SOFTOUCH TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION TO NAVIGATION, DETERMINED THE RESULT AS GOOD, AND ACCEPTED THE REGISTRATION TO PROCEED. DRAPED THE PATIENT AND EXCHANGED THE PATIENT REFERENCE ARRAY TO A STERILE ONE. REMOVED THE EXISTING SHUNT, AND USED THE EXISTING BURR HOLE FOR THE REVISED PLACEMENT. PUT THE NAVIGATED DISPOSABLE STYLET INSIDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11981721 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092467, K192703. 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