Cranial Navigation 4.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04056481143848), received between Feb 22, 2023 and Sep 11, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (15 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, 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Use of Device Problem

  A cranial surgery for a revision of a Ventricular Peritoneal Shunt placement in the brain for drainage of Cerebrospinal fluid (CSF), due to increased intracranial pressure and an incorrectly placed shunt two days before, has been performed with the aid of the Brainlab Cranial Navigation 4.1.After placement of the revision shunt at this surgery, the surgeon received the expected CSF and concluded the surgery. From a post-operative imaging scan, the surgeon determined that the placed revision shunt deviated from its intended position slightly medial, unintendedly deeper and crossing the midline, however still acceptably within the ventricle. According to the surgeon (treating clinician):- The outcome of the surgery was successful as intended, with the desired appropriate CSF flow achieved, without any changes to the planned procedure at the surgery.- There was no (direct or increased) risk of harm to a critical structure due to the deviating shunt placement.- There was no resulting harm or negative effect to the patient due to the deviated shunt placement at this surgery, and there was no prolongation of the surgery / anesthesia.- There were further no remedial actions necessary, don

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50732446 ↗
• InjurySep 11, 2026Use of Device Problem

  A cranial surgery for a planned revision of a Ventricular Peritoneal Shunt placement in the brain for drainage of Cerebrospinal fluid (CSF), due to shunt clogging with increased intracranial pressure, has been performed with the aid of the Brainlab Cranial Navigation 4.1.After placement of the revision shunt, the surgeon received the expected CSF and concluded the surgery. From a post-operative imaging scan, the surgeon determined that the placed revision shunt deviated from its intended position slightly medial and short of the ventricle, i.e. not located within the ventricle as desired. The surgeon decided that a revision surgery is necessary to correct the shunt placement, the revision surgery was planned and took place on (b)(6) 2026.According to the surgeon (treating clinician):- The surgery was a planned surgery, i.e. not an emergency surgery.- There was no (direct or increased) risk of harm to a critical structure due to the deviating shunt placement.- There was no resulting harm or negative effect to the patient, except for that this planned revision shunt placement was not successful as intended.- There were no changes to the planned procedure at the surgery, and the surge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50731934 ↗
• InjuryFeb 18, 2026Use of Device Problem

  A CRANIAL SURGERY FOR A BIOPSY OF A CEREBELLAR LESION HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB SOFTWARE CRANIAL NAVIGATION 4.1. 6 NEEDLE PASSES (AND SAMPLES) WERE ORIGINALLY INTENDED, AND TAKEN, FOR THIS CASE. ONE DAY AFTER THE SURGERY, RESULTS FROM PATHOLOGY SHOWED THE SAMPLES TAKEN TO BE NON-DIAGNOSTIC, AND A CT SCAN REVEALED A DEVIATION OF THE ACTUAL BIOPSY PATH FROM THE PLANNED TRAJECTORY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): A POST-OPERATIVE CT SCAN SHOWED THAT THE BIOPSY HAD BEEN PERFORMED AT A LOCATION THAT WAS CA. 3-5 MM MEDIAL TO THE TUMOR. THERE WAS NO ACTUAL HARM OR NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE DEVIATING BIOPSY PATH IN THE ORIGINAL SURGERY. THERE WAS NO PROLONGATION OF THE ORIGINAL SURGERY/ANESTHESIA (THE DEVIATION WAS DETECTED AFTERWARDS). A SUCCESSFUL REVISION BIOPSY SURGERY WAS PERFORMED TWO DAYS AFTER THE INITIAL SURGERY. THERE WAS NO HARM OR NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE CA. 3-HOUR REPEATED SURGERY/ANESTHESIA FOR THE BIOPSY REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379067 ↗
• InjuryNov 28, 2025Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR RESECTION OF A TUMOR, LOCATED ORBITAL FRONTAL CA. 9 CM DEEP IN THE BRAIN, AND WITH A SIZE OF CA. 0.7CCM, HAS BEEN PLANNED TO BE PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION 4.1. FOR RELAXATION OF THE BRAIN BEFORE TUMOR RESECTION, A CATHETER WAS PLANNED TO BE PLACED IN THE VENTRICLE WITH THE AID OF BRAINLAB CRANIAL NAVIGATION 4.1. WHEN THE CATHETER WAS PLACED TO THE VENTRICLE WITH THE NAVIGATED DISPOSABLE STYLET INSIDE, NO EXPECTED CRANIOSPINAL FLUID (CSF) WAS PRODUCED. UPON VERIFYING ACCURACY USING THE POINTER AT THE REGION OF INTEREST, THE SURGEON DETERMINED THAT NAVIGATION WAS NO LONGER ACCURATE, AND THE TARGET POINT OF THE CATHETER DEVIATED BY CA. 8 MM. AS THE TUMOR WAS ALREADY EXPOSED, THE SURGEON DECIDED TO REMOVE THE CATHETER AND TO CONTINUE THE PROCEDURE WITHOUT NAVIGATION AND WITHOUT BRAIN RELAXATION DRAINAGE. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS PLANNED/INTENDED WITH THE TUMOR RESECTED AS DESIRED. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO DEVIATING BRAIN CATHETER PLACEMENT, ALSO NOT DUE TO THE PROLONGATION OF THE SURGERY/ANESTHESIA OF SOLELY 5 -10 MIN. THERE WERE NO F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670774 ↗
• InjuryOct 30, 2025Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR RESECTION OF A BRAIN TUMOR, LOCATED IN THE RIGHT SUBOCCIPITAL APROX. 3 CM DEEP WITH A SIZE OF CA. 16.5 CCM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION 4.1. WHEN AFTER PATH DISSECTION THE POINTER WAS PLACED IN AN AREA THAT SHOULD CORRESPOND TO TUMOR BASED ON NAVIGATION AND NO TUMOR WAS PRESENT, THE SURGEON DETERMINED THE DISSECTION WAS PERFORMED 3-4 CM SUPERIOR TO THE INTENDED PATH. AT THIS POINT THE SURGEON DECIDED TO CLOSE THE PATIENT, RE-POSITION PRONE AND RE-PIN BEFORE EXTENDING THE CRANIOTOMY (BONE FLAP) INFERIORLY TO BETTER ACCOMMODATE THE RESECTION APPROACH. SURGERY CONTINUED WITHOUT NAVIGATION WITH SUCCESSFUL REMOVAL OF THE TUMOR. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE PATIENT EXPERIENCED MILD LOSS OF VISION ON THE LEFT EYE DUE TO THE DEVIATING SURGICAL ACTIONS PERFORMED IN THE BRAIN (OCCIPITAL LOBE DAMAGE) WITH THE AID OF NAVIGATION. THE EFFECT PERSISTS AT THE CURRENT POINT IN TIME. - THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS PLANNED/INTENDED WITH THE TUMOR RESECTED AS DESIRED. - THERE WAS NO OTHER HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO DEVIATING NAVIGATED ACTIONS, ALSO NOT DUE TO THE PROLONGATION OF THE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Eye / Vision Problem

  MAUDE report 23427637 ↗
• InjurySep 4, 2025Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR REMOVAL OF AN ABSCESS, LOCATED RIGHT TEMPORAL CA. 5CM DEEP IN THE BRAIN, AND WITH A SIZE OF CA. 0.9CCM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION 4.1. WHEN AFTER PATH DISSECTION AT THE FIRST REMOVAL ATTEMPT THE NAVIGATION SHOWED TO BE IN THE ABSCESS, BUT THE SURGEON WAS UNABLE TO SEE THE ABSCESS WITHIN THE BRAIN, AND NEITHER COULD LOCATE IT WITH INDEPENDENT NON-BRAINLAB ULTRASOUND, THE SURGEON DECIDED TO ACQUIRE A CT SCAN INTRA-OPERATIVELY. FROM THE SCAN THE SURGEON DETERMINED THAT THE ABSCESS HAD BEEN MISSED BY CA. 1-1.5CM MAINLY IN THE CRANIAL DIRECTION AND A LITTLE POSTERIOR. THE SURGEON DECIDED TO EXTEND THE CRANIOTOMY (BONE FLAP), AND REMOVED THE ABSCESS SUCCESSFULLY AS INTENDED USING NAVIGATION IN COMBINATION WITH INDEPENDENT ULTRASOUND. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, ALTHOUGH MORE TISSUE WAS RESECTED THAN ORIGINALLY PLANNED. - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 1H. - THERE WERE FURTHER NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. HOSPITALIZATION WAS ALSO N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963368 ↗
• InjuryMar 7, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR THE PLACEMENT OF TWO VENTRICULOPERITONEAL (VP) SHUNTS, INTO THE RIGHT ENCYSTED TEMPORAL HORN AND THE RIGHT LATERAL VENTRICLE, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE, CRANIAL NAVIGATION 4.1. FROM A POST-OPERATIVE CT SCAN, THE SURGEON CONFIRMED THAT THE PLACEMENTS OF BOTH VP SHUNTS DEVIATED FROM THEIR INTENDED POSITIONS. THE SHUNT PLACEMENTS WERE CORRECTED TO THEIR DESIRED POSITIONS DURING A REVISION SURGERY CONDUCTED ON THE SAME DAY, WITH THE AID OF NAVIGATION. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF BOTH VP SHUNT CATHETERS, PLACED WITH THE AID OF NAVIGATION, WAS DETECTED BY THE SURGEON WITH A POST-OPERATIVE CT SCAN AND A REVISION SURGERY TOOK PLACE ON THE SAME DAY. - THE FINAL OUTCOME OF THE REVISION SURGERY, PERFORMED WITH THE AID OF NAVIGATION, WAS SUCCESSFUL AS INTENDED, WITH THE SHUNT PLACEMENTS CORRECT AT THE END OF THE SURGERY. - THERE WAS NO DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THE DEVIATING SHUNT PLACEMENTS. - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENTS, DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 4 HOURS DURING THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21545146 ↗
• InjuryMar 7, 2025Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY TO RESECT A TUMOR IN THE BRAIN WAS PERFORMED WITH THE AID OF THE DISPLAY OF BRAINLAB SOFTWARE CRANIAL NAVIGATION 4.1. DURING THE PROCEDURE, BRAIN TISSUE WAS DISSECTED/RESECTED IN A DIFFERENT LOCATION THAN INTENDED WITH THE BRAINLAB NAVIGATION INVOLVED. WHEN VISIBLY NOT REACHING THE TUMOR AS EXPECTED, THE SURGEONS DECIDED TO INTERRUPT THE SURGERY AND TO PERFORM A CT SCAN FOR THE PATIENT. THE SAME TUMOR RESECTION SURGERY WAS COMPLETED SUCCESSFULLY AS INTENDED WITH NAVIGATION, USING THE CT SCAN PERFORMED AT THIS SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF THE ACTUAL TUMOR RESECTION PATH IN THE BRAIN FROM THE INTENDED TRAJECTORY WAS DETECTED BY THE SURGEON VISUALLY DURING THE SURGERY, AND THE SURGERY WAS CONTINUED SUCCESSFULLY WITHOUT CHANGES OF THE SKULL OPENING AND WITH THE USE OF NAVIGATION. - THE OUTCOME OF THIS SURGERY WAS SUCCESSFUL AS PLANNED/INTENDED WITH THE REMOVAL OF THE TUMOR AT THE END OF THE SURGERY. - THE PATIENT DEVELOPED A SPEECH PROBLEM ("TROUBLE FINDING WORDS") DUE TO THE DEVIATING SURGICAL ACTIONS PERFORMED IN THE BRAIN WITH THE AID OF NAVIGATION. - THERE WAS NO FURTHER HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO DE

  Patient problems: Speech Disorder

  MAUDE report 21545011 ↗
• InjuryFeb 18, 2025Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A SHUNT PLACEMENT INTO THE RIGHT-SIDE VENTRICLE OF THE BRAIN, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB CRANIAL NAVIGATION 4.1. FROM AN POST-PLACEMENT IMAGING SCAN THE SURGEON DISCOVERED THE SHUNT DEVIATED FROM ITS INTENDED POSITION BY CA. 2-3CM, AND INTO THE BRAINSTEM. THE SHUNT PLACEMENT WAS CORRECTED TO ITS DESIRED POSITION DURING THE SAME SURGERY WITH THE AID OF NAVIGATION. ACCORDING TO THE HOSPITAL (CLINICAL SPECIALIST): THE DEVIATION OF THE SHUNT PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY WITH A POST-PLACEMENT IMAGING SCAN, AND THE SHUNT WAS CORRECTED TO ITS DESIRED POSITION WITH NAVIGATION AT THE VERY SAME SURGERY. THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING INITIAL PLACEMENT, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONG OF CA. 1 HOUR. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396373 ↗
• InjuryJan 30, 2025Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A CATHETER PLACEMENT AND A TUMOR RESECTION IN THE OCCIPITAL LOBE, CA. 40MM DEEP IN THE BRAIN WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL NAVIGATION 4.1 (ON 3 JANUARY 2025). FROM AN INTRA-OPERATIVE CT SCAN THE SURGEON DISCOVERED THE CATHETER DEVIATED FROM THE INTENDED POSITION BY CA 5MM LATERALLY. IT WAS CORRECTED TO ITS DESIRED POSITION DURING THE SAME SURGERY WITH THE AID OF NAVIGATION. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF THE CATHETER PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND THE CATHETER WAS CORRECTED TO ITS INTENDED POSITION WITH NAVIGATION AT THE VERY SAME SURGERY. - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH THE CATHETER PLACEMENT CORRECT AT THE END OF THE SURGERY. - THERE WAS NO DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THE DEVIATING PLACEMENT. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING INITIAL PLACEMENT, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONG OF 1.5 HOURS. - THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272589 ↗
• InjuryNov 20, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A BIOPSY OF A TUMOR LESION, LOCATED CA 49MM DEEP IN THE RIGHT FRONTAL LOBE OF THE BRAIN, WITH A SIZE OF CA 10X14MM HAS BEEN PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB CRANIAL NAVIGATION SOFTWARE CRANIAL NAVIGATION 4.1. ONE BIOPSY PASS WAS INTENDED. FROM AN INTRA-OPERATIVE CT SCAN THE SURGEON DISCOVERED THAT THE BIOPSY TRAJECTORY DEVIATED BY CA. 9 MM FROM THE INTENDED PATH AND TARGET IN THE BRAIN. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE PURPOSE OF THE PLANNED SURGERY WAS TO ONLY RECEIVE DIAGNOSTIC SAMPLES AND NOT TO REMOVE THE LESION AND/OR TREAT THE DISEASE. THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE (E.G., BRAIN TISSUE/STRUCTURE, BLOOD VESSELS, ETC.) DUE TO THE DEVIATION OF THE BIOPSY NEEDLE FROM THE INTENDED TRAJECTORY, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 30-60 MINUTES. THERE WERE FURTHER NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. THERE WAS NO PROLONGATION OF HOSPITALIZATION EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734245 ↗
• InjuryOct 22, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR THE PLACEMENT OF AN EXTERNAL VENTRICULAR DRAIN (EVD) INTO THE RIGHT VENTRICLE, CA. 5.5 CM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL NAVIGATION 4.1. FROM AN INTRA-OPERATIVE CT SCAN THE SURGEON DISCOVERED THAT THE SHUNT WAS PLACED CA. 3 MM LATERAL TO ITS INTENDED POSITION. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - EVEN THOUGH THE FLOW OF CEREBROSPINAL FLUID (CSF) WAS ACHIEVED BY THE END OF THE SURGERY, THE SHUNT WAS NOT PLACED IN THE INTENDED POSITION AND THERE WAS A POSSIBILITY THAT THE PATIENT WOULD NEED A REVISION SURGERY TO PLACE A PERMANENT SHUNT. - A MINOR INTRACRANIAL HEMORRHAGE OCCURRED DUE TO THE DEVIATING SHUNT PLACEMENT AND A REPEAT CT SCAN WAS NEEDED TO CONFIRM THAT IT WAS NOT ENLARGING. - THERE WAS NO OTHER HARM OR NEGATIVE EFFECT TO THE PATIENT, ALSO NOT DUE TO THE PROLONGED ANESTHESIA OF 90 TO 120 MINUTES. - THERE WERE NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 20505676 ↗
• InjurySep 13, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A TUMOR RESECTION, HAS BEEN PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL NAVIGATION APP 4.1. A PRE-OPERATIVE MR SCAN, ACQUIRED 5 DAYS BEFORE THE SURGERY, WAS USED TO REGISTER THE PATIENT ANATOMY TO NAVIGATION. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. - PERFORMED THE PATIENT REGISTRATION ON THE PRE-OPERATIVE MR 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. - REMOVED THE UNSTERILE ARRAY, DRAPED THE PATIENT, AND PLACED THE STERILE ARRAY. - USED THE POINTER TO DETERMINE THE LOCATION OF THE SKIN OPENING AND TO DRAW THE CRANIOTOMY. - OPENED THE SKULL AND RECOGNIZED THE NAVIGATION INACCURACY DUE TO APPARENT BLEEDING OF THE SINUS SUPERIOR. - REPAIRED THE BLEEDING AND CONTINUED THE SURGERY WITHOUT THE USE OF NAVIGATION. - SUCCESSFULLY REMOVED THE TUMOR AND CLOSED THE PATIE

  Patient problems: Intracranial Hemorrhage

  MAUDE report 20210936 ↗
• InjuryMar 28, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY ON THE LEFT TEMPORAL LOBE, FOR TUMOR RESECTION WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL NAVIGATION 4.1. A PRE-OPERATIVE CT SCAN ACQUIRED CA. 2 WEEKS BEFORE SURGERY WAS USED TO REFERENCE THE NAVIGATION DISPLAY TO THE PATIENT ANATOMY. 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 4-SPHERE STANDARD PATIENT REFERENCE ARRAY FOR NAVIGATION TO THE NON-BRAINLAB HEAD HOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON A PREOPERATIVE MR SCAN USING THE BRAINLAB SOFTOUCH AND Z-TOUCH TO ACQUIRE POINTS ON THE PATIENT'S SKIN THAT MATCHED THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT'S ANATOMY. DID NOT ACCEPT THE REGISTRATION AFTER VERIFYING ITS ACCURACY. PERFORMED THE SECOND PATIENT REGISTRATION ON THE PREOPERATIVE CT SCAN. VERIFIED THE ACCURACY OF THE SECOND REGISTRATION, OPTED TO IMPROVE IT BY ACQUIRING ADDITIONAL POINTS ON THE PATIENT'S SKIN, REVERIFIED THE ACCURACY AND ACCEPTED IT TO PROCEED. MARKED POINTS ON THE SKIN TO DENOTE THE TUMOR, CRANIOTOMY, AND SKIN INCISION BEFORE DRAPING. AFTER DRAPING AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997448 ↗
• InjuryFeb 22, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY (ON (B)(6) 2023) FOR DIAGNOSTIC BIOPSY OF A LESION OF APPROXIMATELY 3CM SQ LOCATED AT A DEPTH OF ABOUT 60MM IN THE LEFT TEMPORAL LOBE, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SOFTWARE CRANIAL NAVIGATION APP 4.1.0. A PRE-OPERATIVE MRI WAS ACQUIRED PRIOR TO THE SURGERY FOR USE WITH NAVIGATION. THE TRAJECTORY WAS PLANNED PRE-OPERATIVELY. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT SUPINE IN A NON-BRAINLAB HEAD HOLDER AND ATTACHED THE UNSTERILE NAVIGATION REFERENCE - 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 (AT VARIOUS LANDMARKS USING THE POINTER), JUDGED ACCURACY TO BE VERY GOOD, AND ACCEPTED THE RESULT TO PROCEED - MARKED THE INTENDED ENTRY POINT ON THE PATIENT'S SKIN USING THE POINTER, DRAPED THE PATIENT, AND EXCHANGED THE UNSTERILE NAVIGATION REFERENCE FOR A STERILE ONE - VERIFIED THE ACCURACY OF THE NAVIGATION AGAIN AND DID NOT DETECT ANY DEVIATION - MADE THE SKIN INCISION AND CREATED A BURR HOLE IN THE SKULL AT THE PREDETERMINED ENTRY POINT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416522 ↗