Alignment Software Cranial 2.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04056481144487), received between Jul 26, 2024 and Mar 10, 2026 — classified as 14 injuries.

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

• InjuryMar 10, 2026Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A BIOPSY OF A LESION IN THE LEFT FRONTAL REGION OF THE BRAIN HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB SOFTWARE ALIGNMENT SOFTWARE 2.0. 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): THE SURGERY WAS NOT SUCCESSFUL AS THE DESIRED PATHOLOGICAL/DIAGNOSTIC SAMPLE WAS NOT OBTAINED FROM THE TARGET LESION. THERE WAS NO NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE ACTUAL BIOPSY PATH IN THE BRAIN DEVIATING FROM THE PLANNED TRAJECTORY. THERE IS A PLAN TO RE-DO THE BIOPSY, WITHOUT THE AID OF BRAINLAB NAVIGATION. THERE WERE NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556159 ↗
• InjuryFeb 6, 2026Use of Device Problem

  A CRANIAL SURGERY FOR PLACEMENT OF 11 SEEG (STEREOELECTROENCEPHALOGRAPHY) ELECTRODES IN THE BRAIN OF A PATIENT WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB ALIGNMENT SOFTWARE CRANIAL 2.0. PRE-OPERATIVE CT & MRI SCANS WERE ACQUIRED 3 DAYS BEFORE THE SURGERY TO BE USED FOR THE REGISTRATION OF THE PATIENT'S ANATOMY TO THE NAVIGATION DURING THE PROCEDURE. THE SEEG ELECTRODE TRAJECTORIES WERE PLANNED BEFORE THE SURGERY USING THE PRE-OPERATIVELY ACQUIRED MRI DATA SET. AN INTRA-OPERATIVE CT SCAN REVEALED THAT FIVE ELECTRODES PLACED IN THE BRAIN, WITH THE AID OF NAVIGATION, DEVIATED FROM THEIR PLANNED TRAJECTORIES. THE POSITIONS OF THE DEVIATING ELECTRODES WERE NOT CORRECTED. IT WAS LATER DETECTED ON A POST-OPERATIVE CT SCAN THAT ALL ELECTRODES HAD BEEN PLACED IN DIFFERENT LOCATIONS IN THE BRAIN THAN INTENDED. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF ELECTRODES PLACED IN THE BRAIN WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY. THE POSITIONS OF THE DEVIATING ELECTRODES WERE NOT CORRECTED. - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL. - THERE WAS NO ACTUAL NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE DEVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279028 ↗
• InjuryNov 20, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A BIOPSY OF A LESION, LOCATED RIGHT PARIETAL CA. 53MM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB ALIGNMENT SOFTWARE CRANIAL 2.0. FROM A POST-OPERATIVE MRI SCAN THE SURGEON DETERMINED THAT THE BIOPSY PATH AND LOCATION HAD DEVIATED FROM THE PLANNED TRAJECTORY SHIFTED BY CA. 15-20 MM AT TARGET AND ENTRY, WITH THE SAMPLES TAKEN AT THE EDGE OF THE LESION MASS. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE PURPOSE OF THIS SURGERY WAS TO RECEIVE A DIAGNOSTIC SAMPLE, NOT TO REMOVE OR TREAT THE LESION. - THE DESIRED PATHOLOGICAL/DIAGNOSTIC TISSUE WAS RETRIEVED WITH NAVIGATION AT THE VERY SAME SURGERY. - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT RESULTING DUE TO THE DEVIATING BIOPSY PATH AND LOCATION, AND THERE WAS NO SURGERY/ANESTHESIA PROLONGATION SINCE THERE WERE NO CHANGES TO THE PLANNED SURGERY PROCEDURE DONE. - THERE WERE FURTHER NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. THERE WAS ALSO NO PROLONGATION OF HOSPITALIZATION.

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

  MAUDE report 23604520 ↗
• InjuryOct 22, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A BIOPSY OF A LESION, LOCATED RIGHT PARIETAL CA. 36MM DEEP IN THE BRAIN, AND WITH A SIZE OF CA. 3.12CCM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB ALIGNMENT SOFTWARE CRANIAL 2.0. 10 BIOPSY PASSES IN ONE TRAJECTORY WERE INTENDED. AFTER THE FIRST BIOPSY PASS ATTEMPT THE SURGEON NOTICED THE SAMPLE LOOKED LIKE NORMAL BRAIN TISSUE AND CONTINUED TO TAKE THE FURTHER SAMPLES AS INTENDED IN DIFFERENT DEPTHS IN THE SAME PATH - PATHOLOGY RETURNED THAT DESIRED DIAGNOSTIC TISSUE WAS CONTAINED IN THE SAMPLING. FROM A POST-OPERATIVE MRI SCAN THE SURGEON DETERMINED THAT THE BIOPSY PATH AND LOCATION HAD DEVIATED FROM THE PLANNED TRAJECTORY SHIFTED BY CA. 5-6MM INFERIORLY, WITH THE SAMPLES TAKEN AT THE EDGE OF THE LESION MASS AND UNDERNEATH IT. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE PURPOSE OF THIS SURGERY WAS TO RECEIVE A DIAGNOSTIC SAMPLE, NOT TO REMOVE OR TREAT THE LESION. THE DESIRED PATHOLOGICAL/DIAGNOSTIC TISSUE WAS RETRIEVED WITH NAVIGATION AT THE VERY SAME SURGERY. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT RESULTING DUE TO THE DEVIATING BIOPSY PATH AND LOCATION, AND THERE WAS NO SURGERY/ANESTHESIA PROLONGATION SINCE THERE WERE NO CHANGES TO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355405 ↗
• InjuryAug 14, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A BIOPSY OF A LESION LOCATED IN THE BRAIN HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB ALIGNMENT SOFTWARE CRANIAL 2.0. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO GET THE CONFIRMED DIAGNOSTIC SAMPLE, INDICATING THAT THE BIOPSY MAY NOT HAVE BEEN PERFORMED AT THE INTENDED LOCATION. 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: Insufficient Information; Intracranial Hemorrhage; Speech Disorder

  MAUDE report 22803795 ↗
• InjuryJul 7, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A BIOPSY OF A CA. 6.35 CCM LESION, LOCATED IN THE OCCIPITAL REGION OF THE BRAIN, AT CA. 38 MM DEEP, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB ALIGNMENT SOFTWARE CRANIAL 2.0 (ON (B)(6) 2025). AFTER SAMPLES WERE TAKEN, THE RESULTS WERE INCONCLUSIVE. THE SURGEON DECIDED TO CHANGE THE PROCEDURE TO AN OPEN BIOPSY, AND CONTINUED WITHOUT USE OF NAVIGATION. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - AFTER THE DESIRED SAMPLE WAS NOT OBTAINED WITH AID OF NAVIGATION (RESULTS WERE INCONCLUSIVE), THE SURGEON CHANGED TO AN OPEN BIOPSY, AND COMPLETED THE SURGERY WITHOUT AID OF NAVIGATION. - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED (DIAGNOSTIC SAMPLE WAS COLLECTED). - THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THE POTENTIALLY UNINTENDED TISSUE RESECTIONS. - THERE WAS NEITHER HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE POTENTIALLY UNINTENDED TISSUE RESECTIONS NOR DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF 1H. - THERE WERE FURTHER NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THE POTENTIALLY UNINTENDED TISSUE RESECTIONS. THERE WAS ALSO NO PROLONGATION OF HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412982 ↗
• InjuryMay 2, 2025Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR PLACEMENT OF 2 RESPONSIVE NEUROSTIMULATION (RNS) ELECTRODES FOR EPILEPSY TREATMENT, TARGETING BILATERAL RIGHT AND LEFT TEMPORAL IN THE BRAIN, CA. 110MM AND 113MM DEEP, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB ALIGNMENT SOFTWARE CRANIAL 2.0. AFTER PLACING THE RIGHT TEMPORAL DEPTH ELECTRODE WITH NAVIGATION, THE SURGEON OBSERVED THAT THE PATIENT HEAD HAD MOVED IN THE NON-BRAINLAB HEAD HOLDER, AND DETERMINED WITH A FOLLOWING INTRA-OPERATIVE CT SCAN, THAT THE RIGHT ELECTRODE DEVIATED FROM ITS PLANNED POSITION SLIGHTLY SUPERIOR. THE SURGEON REMOVED THE ELECTRODE, EXTENDED THE BURR HOLE (SKULL OPENING) BY A FEW MM, AND RE-PLACED THE RIGHT ELECTRODE WITH NAVIGATION. AFTER ALSO THE LEFT TEMPORAL DEPTH ELECTRODE WAS PLACED WITH NAVIGATION, THE SURGEON DETERMINED FROM A VERIFICATION INTRA-OPERATIVE CT SCAN, THAT THE RIGHT ELECTRODE STILL DEVIATED BY CA. 3.5MM FROM THE INTENDED TARGET POINT, AND THE LEFT ELECTRODE BY CA. 2MM. SINCE THE IMPEDANCE MEASUREMENTS WERE SATISFACTORY FOR THE INTENDED TREATMENT, THERE WERE NO FURTHER ATTEMPTS NECESSARY OR DONE TO ADJUST THE ELECTRODE PLACEMENTS. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE FINAL OUTCOME OF THIS SURGER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21948423 ↗
• InjuryApr 17, 2025Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A BIOPSY OF A CA. 29 CM^3 LESION, LOCATED IT THE INFRATENTORIAL REGION OF THE BRAIN, POSTERIOR TO THE BRAINSTEM, AT CA. 36 MM DEEP, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB ALIGNMENT SOFTWARE CRANIAL 2.0. FROM AN INTRA-OPERATIVE CT SCAN THE SURGEON DISCOVERED THAT THE BIOPSY NEEDLE DEVIATED FROM THE INTENDED TRAJECTORY BY CA. 11 MM POSTERIORLY AT THE ENTRY POINT AND CA. 6 MM POSTERIORLY AT THE TARGET POINT. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF THE BIOPSY NEEDLE PLACED IN THE BRAIN WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, HOWEVER ITS POSITION WAS NOT CORRECTED AS THE PRESENCE OF THE TUMOR TISSUE WAS CONFIRMED FROM THE COLLECTED SAMPLES. - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. - THERE WAS NO ACTUAL HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENT OF THE BIOPSY NEEDLE, DESPITE A DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE AS THE NEEDLE TRAJECTORY CAME IN VERY CLOSE PROXIMITY TO THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) AND THE 4TH VENTRICLE. - THE SURGERY/ANESTHESIA WAS NOT PROLONGED AS RESULT OF THIS ISSUE. - THERE WERE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855366 ↗
• InjuryApr 16, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR AN ABLATION OF A LESION, LOCATED CA. 80MM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB ALIGNMENT SOFTWARE CRANIAL 2.0. PLACEMENT OF ONE LASER FIBER WAS INTENDED, WITH A NAVIGATED BIOPSY OF THE TUMOR BEFOREHAND WITH 1 PASS WITHIN THE SAME PATH. AFTER PERFORMING THE BIOPSY SUCCESSFULLY WITH THE DESIRED DIAGNOSTIC SAMPLE RETRIEVED, AND PLACING THE LASER FIBER, THE SURGEON DETECTED FROM A PRE-ABLATION IMAGING SCAN, THAT THE LASER FIBER PATH AND TARGET POINT WAS DEVIATING SLIGHTLY FROM ITS INTENDED/PLANNED LOCATION. CORRESPONDINGLY, THE BIOPSY PATH AND TARGET HAD DEVIATED IN THE SAME WAY. THE SURGEON DECIDED TO USE THE CURRENT LASER FIBER PLACEMENT FOR THE LITT TREATMENT AND, WITHOUT ANY CHANGES, CONTINUED WITH THE ABLATION - MOST OF THE LESION WAS SUCCESSFULLY ABLATED AT THE VERY SAME SURGERY, ALTHOUGH NOT ALL OF IT AS ORIGINALLY DESIRED. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF THE LASER FIBER PLACED WAS DETECTED BY THE SURGEON WITH AN MRI BEFORE ADMINISTERING THE THERMAL LASER TREATMENT IN THE BRAIN. - THE OUTCOME OF THE BEFOREHAND BIOPSY WAS SUCCESSFUL AS INTENDED, WI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21846771 ↗
• InjuryApr 11, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A BIOPSY OF A LESION LOCATED IN THE BRAIN HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB ALIGNMENT SOFTWARE CRANIAL 2.0. 1 NEEDLE PASS WITH 5 SAMPLES WAS ORIGINALLY INTENDED, AND A TRAJECTORY WAS PLANNED BEFORE THE SURGERY USING A PRE-OPERATIVE MRI SCAN OF THE PATIENT ACQUIRED 30 DAYS BEFORE THE SURGERY. FROM AN INTRA-OPERATIVE SCAN, PERFORMED AFTER THE SAMPLES HAD BEEN COLLECTED, THE SURGEON DISCOVERED THAT THE BIOPSY TRAJECTORY DEVIATED FROM THE INTENDED PATH AND TARGET IN THE BRAIN. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THERE WAS NO ACTUAL HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING BIOPSY PATH IN THE BRAIN, DESPITE A DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE (TRANSGRESSING A VENTRICLE WHICH INCREASED THE RISK OF HYDROCEPHALUS, BLEEDING OR INFECTIOUS COMPLICATIONS). THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 15 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 21824351 ↗
• InjuryDec 13, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A BIOPSY OF LESIONS IN THE BRAIN, LOCATED ON THE RIGHT SIDE NEAR THE POSTERIOR FOSSA AND WITH A SIZE OF CA. 17MM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB ALIGNMENT SOFTWARE CRANIAL 2.0. 1 PASS AND 4 SAMPLES WITHIN THE SAME PATH WERE INTENDED. THE SURGEON DETECTED FROM A POST-OPERATIVE CT SCAN, THAT THE BIOPSY PATH AND LOCATION HAD DEVIATED SHIFTED BY CA. 5MM MEDIAL FROM ITS INTENDED/PLANNED LOCATION, AND THE DESIRED DIAGNOSTIC SAMPLE WAS NOT RETRIEVED AT THIS SURGERY. A REVISION SURGERY WAS SCHEDULED TO RETRIEVE THE DESIRED PATHOLOGICAL SAMPLE AND TOOK PLACE ON (B)(6) 2024. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE PURPOSE OF THIS SURGERY WAS TO RECEIVE A DIAGNOSTIC SAMPLE, NOT TO REMOVE OR TREAT THE LESIONS. - THE OUTCOME OF THE REVISION SURGERY WAS SUCCESSFUL AS INTENDED, USING THE EXISTING BURR HOLE IN THE SKULL FROM THE ORIGINAL SURGERY, WITH THE DESIRED PATHOLOGICAL SAMPLE RETRIEVED. - THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING BRAIN BIOPSY AT THE ORIGINAL SURGERY. - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING BIOPSY, AND ALSO NOT DUE TO THE REPEAT SURGERY/AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926656 ↗
• InjuryDec 10, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR AN ABLATION OF A TUMOR, LOCATED RIGHT OCCIPITAL CA. 36MM DEEP IN THE BRAIN AND WITH A SIZE OF CA. 15MM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB ALIGNMENT SOFTWARE CRANIAL 2.0. PLACEMENT OF ONE LASER FIBER WAS INTENDED, WITH A BIOPSY OF THE TUMOR BEFOREHAND WITH 4 PASSES AND SAMPLES WITHIN THE SAME PATH. AFTER PERFORMING THE BIOPSY WITH UNKNOWN OUTCOME - AS THE SURGEON HAD NOT REVIEWED THE PATHOLOGY RESULTS YET- AND PLACING THE LASER FIBER, THE SURGEON DETECTED FROM A PRE-ABLATION MRI SCAN, THAT THE LASER FIBER PATH AND TARGET POINT WAS DEVIATING FROM ITS INTENDED/PLANNED LOCATION, SHIFTED BY CA. 8MM LATERAL AND POSTERIOR. CORRESPONDINGLY, THE BIOPSY PATH AND TARGET HAD DEVIATED IN THE SAME WAY. THE SURGEON DETERMINED THE CURRENT LASER FIBER PLACEMENT AS USABLE FOR THE LITT TREATMENT AND, WITHOUT ANY CHANGES, CONTINUED WITH THE TUMOR ABLATION AND COMPLETED IT SUCCESSFULLY AS INTENDED. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF THE LASER FIBER PLACED WAS DETECTED BY THE SURGEON WITH AN MRI BEFORE ADMINISTERING THE THERMAL LASER TREATMENT IN THE BRAIN. - THE OUTCOME OF THE BIOPSY IS UN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893770 ↗
• InjuryNov 29, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR AN ABLATION OF A TUMOR (GLIOBLASTOMA), LOCATED LEFT TEMPORAL CA. 52MM DEEP IN THE BRAIN AND WITH A SIZE OF CA. 34.5CCM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB ALIGNMENT SOFTWARE CRANIAL 2.0. PLACEMENT OF TWO LASER FIBERS WAS INTENDED, WITH A BIOPSY OF THE TUMOR BEFOREHAND WITH 2-3 PASSES AND SAMPLES WITHIN THE SAME PATH. AFTER PERFORMING THE BIOPSY SUCCESSFULLY WITH THE PATHOLOGICAL SAMPLE RETRIEVED AS DESIRED, AND PLACING THE LASER FIBERS, THE SURGEON DETECTED FROM PRE-ABLATION MRI SCANS, THAT THE LASER FIBER PATHS AND TARGET POINTS WERE DEVIATING FROM THEIR INTENDED/PLANNED LOCATIONS, SHIFTED INFERIOR BY CA. 4MM. CORRESPONDINGLY, THE BIOPSY PATH AND TARGET -DESPITE SUCCESSFUL AS DESIRED- HAD DEVIATED IN THE SAME WAY. THE SURGEON DETERMINED THE CURRENT LASER FIBER PLACEMENTS AS STILL SAFE FOR THE LITT TREATMENT AND CONTINUED THE TUMOR ABLATION, WITHOUT ANY CHANGES. THE TUMOR WAS SUCCESSFULLY ABLATED, WHEREAS A COMPLETE ABLATION OF THE TUMOR WAS NOT POSSIBLE, WHICH WAS DUE TO CLINICAL REASONS, E.G. THE SIZE OF THE TUMOR, UNRELATED TO THE LASER FIBER PLACEMENTS. ACCORDING TO THE HOSPITAL (CLINICIAN, LEAD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808922 ↗
• InjuryJul 26, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A REPEAT BIOPSY OF A CA. 9 MM3 LESION LOCATED IN THE BRAIN WAS PERFORMED WITH THE AID OF THE BRAINLAB ALIGNMENT SOFTWARE CRANIAL 2.0. EIGHT SAMPLES WERE ORIGINALLY INTENDED, AND A TRAJECTORY WAS PLANNED ONE DAY BEFORE SURGERY USING A PRE-OPERATIVE MRI T1 SCAN OF THE PATIENT ACQUIRED ONE DAY BEFORE THE SURGERY. DURING THE PROCEDURE, THE SURGEON: - POSITIONED THE PATIENT'S HEAD IN A PRONE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER AND ATTACHED THE 4-SPHERE NAVIGATION REFERENCE ARRAY TO THE REFERENCE ARM. - ATTEMPTED A LANDMARK REGISTRATION WITH FIDUCIALS PLACED ON THE PATIENT. - DECIDED TO PERFORM SURFACE MATCH REGISTRATION 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. - PREFERRED THE LATTER REGISTRATION AND AFTER VERIFICATION USING THE SOFTOUCH DEEMED IT ACCEPTABLE IT TO PROCEED. - PLANNED THE ENTRY POINT OF THE SKIN INCISION AND MARKED IT AS A LANDMARK FOR ACCURACY VERIFICATION AFTER DRAPING. - PREPARED, DRAPED THE PATIENT AND SWITCHED OUT THE NON-STERILE 4-SPHERE NAVIGATION REFERENCE ARRAY FOR A STERILE ONE. - VERIFIED THE NAVIGATION ACCURACY AND DEEMED IT ACCEPT

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19837249 ↗