BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE & TRAUMA NAVIGATION (VERSION 2.0)

    MDR report key: 23289421 · Received October 15, 2025

    Report

    Report Number
    8043933-2025-00072
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 31, 2025
    Manufacturer
    BRAINLAB SE
    Product Code
    OLO
    UDI-DI
    04056481143954
    PMA / PMN Number
    K221618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2, H1: A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE ONE SCREW WAS PLACED IN THE PATIENT'S SPINE IN A DIFFERENT POSITION THAN DESIRED WITH BRAINLAB NAVIGATION INVOLVED, AND COULD HAVE LED TO HARM OF THE SPINAL CORD AND/OR BLOOD VESSELS, AND THUS IN A WORST CASE SCENARIO ULTIMATELY TO SERIOUS HARM TO THE PATIENT. A COMPREHENSIVE INVESTIGATION BY BRAINLAB REGARDING THIS SPECIFIC EVENT IS CURRENTLY ONGOING AND FINAL CONCLUSIONS ARE PENDING. BRAINLAB PLANS TO ISSUE A FOLLOW-UP REPORT UPON COMPLETION OF THE INVESTIGATION. H6, H7: A COMPREHENSIVE INVESTIGATION BY BRAINLAB REGARDING THIS SPECIFIC EVENT IS CURRENTLY ONGOING AND FINAL CONCLUSIONS ARE PENDING. BRAINLAB PLANS TO ISSUE A FOLLOW-UP REPORT TO THE FDA UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    B2, H1: A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE TWO SCREWS WERE PLACED IN THE PATIENT'S SPINE IN DIFFERENT POSITIONS THAN DESIRED WITH BRAINLAB NAVIGATION INVOLVED. DESPITE CONTINUED FOLLOW-UP, FURTHER DETAILS OF THE EFFECTS ON THE PATIENT COULD NOT BE RETRIEVED FROM THE HOSPITAL. - THERE WAS NEITHER HARM NOR NEGATIVE EFFECT ON THE PATIENT REPORTED DUE TO THE DEVIATING SPINE SCREW PLACEMENTS. - THERE WAS NO PROLONGATION OF THE SURGERY/ANESTHESIA REPORTED DUE TO THIS ISSUE. - NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT WERE REPORTED THAT WOULD HAVE BEEN DONE, NECESSARY OR PLANNED, AND NO PROLONGATION OF HOSPITALIZATION WAS REPORTED. H6: ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE LIMITED INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE MOST LIKELY ROOT CAUSE OF THE TWO SPINE SCREWS PLACED AT C3, WITH AID OF NAVIGATION, DEVIATING FROM THEIR INTENDED TARGET POINTS IS A COMBINATION OF: - THE DIFFERENCE IN PATIENT POSITIONING BETWEEN THE PRE-OPERATIVE SCAN (USED FOR REGISTRATION AND NAVIGATION) AND THE SURGERY. THE PRE-OP CT SCAN USED FOR PATIENT REGISTRATION WAS OBTAINED WHILE THE PATIENT WAS POSITIONED SUPINE, WHILE DURING THE PROCEDURE, THE PATIENT WAS POSITIONED PRONE. IMAGING DATA ACQUIRED FROM THIS SURGERY SHOWED THAT VERTEBRA C2 WAS IN A DIFFERENT POSITION WHEN THE PATIENT'S ORIENTATION WAS SUPINE VERSUS PRONE. THE DECISION TO EXTEND THE TARGET POINTS OF THE SPINE SCREWS BEYOND THE VERTEBRA THAT WAS REGISTERED USING THIS SPECIFIC PRE-OPERATIVE CT MADE THE PLACEMENTS PRONE TO AN INACCURACY THAT CAUSED THE SCREW TIPS TO DEVIATE FROM THE INTENDED TARGET POINTS (C2). - RELATIVE MOVEMENTS OF THE PATIENT ANATOMY DURING THE SURGERY BETWEEN THE LOCATION THE NAVIGATION REFERENCE ARRAY WAS FIXATED TO (C3), AND THE TARGET POINTS OF THE SPINE SCREWS (C2). MULTI-LEVEL NAVIGATION - I.E. OPERATING ON A DIFFERENT VERTEBRA THAN THE ONE THE PATIENT REFERENCE ARRAY FOR NAVIGATION IS FIXATED TO OR OPERATING ACROSS MULTIPLE VERTEBRAE WITHOUT REMOUNTING THE PATIENT REFERENCE AND REREGISTERING - ESPECIALLY IF THE CONNECTION IN BETWEEN THE VERTEBRAE IS NOT RIGID - MAY RESULT IN RELATIVE MOVEMENTS OF THE VERTEBRAE (ACTUAL ANATOMY) DURING THE SURGERY THAT CANNOT BE COMPENSATED BY THE NAVIGATION SOFTWARE DISPLAYING INSTRUMENT POSITIONS ON THE REGISTERED PRE-PLACEMENT PATIENT IMAGE SCAN. MULTI-LEVEL NAVIGATION IS SPECIFICALLY NOT RECOMMENDED FOR CERVICAL CASES. APPARENTLY, THE RESULTING DEVIATION OF THE INSTRUMENT LOCATIONS DISPLAYED BY THE NAVIGATION COMPARED TO THEIR POSITIONS ON AND IN THE ACTUAL PATIENT ANATOMY DURING THE PLACEMENTS, WAS NOT RECOGNIZED BY THE USER WITH THE NECESSARY NAVIGATION ACCURACY VERIFICATION OF THE REGISTRATION, AND CONTINUOUSLY THROUGHOUT THE PROCEDURE, BEFORE AND DURING THE PREPARATIONS AND SCREW PLACEMENTS INTO THE AFFECTED VERTEBRAE. THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE (NAVIGATION). CORRESPONDING BRAINLAB MEASURES TO MINIMIZE THIS ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE. H7: BRAINLAB INTENDS TO RE-ITERATE THE RELEVANT TOPICS REGARDING THE USE OF THE DEVICE TO THIS CUSTOMER.

    Description of Event or Problem · 0

    AN OPEN SURGERY ON THE CERVICAL SPINE FOR FUSION OF VERTEBRAE C3 - C4 WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE CONFIRMATION SCAN, THE SURGEON DETERMINED THAT ONE SPINE SCREW PLACED IN VERTEBRA C3, WITH THE AID OF NAVIGATION, DEVIATED FROM ITS INTENDED POSITION. THE MISPLACED SCREW WAS REPORTEDLY REMOVED AND REPLACED DURING THE SAME SURGERY. FURTHER DETAILS OF THE EFFECTS ON THE PATIENT COULD NOT YET BE RETRIEVED FROM THE HOSPITAL. BRAINLAB CONTINUES TO FOLLOW UP WITH THE HOSPITAL.

    Description of Event or Problem · 0

    AN OPEN SURGERY ON THE CERVICAL SPINE, WITH INTENDED PLACEMENT OF 2 SPINE SCREWS AT C3, WITH TARGET POINTS EXTENDING INTO C2, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE VERIFICATION SCAN, THE SURGEONS DISCOVERED THAT BOTH SCREWS, PLACED WITH THE AID OF NAVIGATION, DEVIATED LATERALLY FROM THEIR INTENDED POSITIONS AT THE TARGET POINTS. ONE OF THE MISPLACED SCREWS WAS REPORTEDLY REMOVED AND REPLACED WITH A SHORTER SCREW DURING THE SAME SURGERY. DESPITE CONTINUED FOLLOW-UP, FURTHER DETAILS OF THE EFFECTS ON THE PATIENT COULD NOT BE RETRIEVED FROM THE HOSPITAL. - THERE WAS NEITHER HARM NOR NEGATIVE EFFECT ON THE PATIENT REPORTED DUE TO THE DEVIATING SPINE SCREW PLACEMENTS. - THERE WAS NO PROLONGATION OF THE SURGERY/ANESTHESIA REPORTED DUE TO THIS ISSUE. - NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT WERE REPORTED THAT WOULD HAVE BEEN DONE, NECESSARY OR PLANNED, AND NO PROLONGATION OF HOSPITALIZATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2597279 SPINE & TRAUMA NAVIGATION (VERSION 2.0) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC OLO BRAINLAB SE 22268-04 SW V. 2.0.1 04056481143954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other