BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE & TRAUMA NAVIGATION 2.0.

    MDR report key: 23849910 · Received December 19, 2025

    Report

    Report Number
    8043933-2025-00095
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 19, 2025
    Manufacturer
    BRAINLAB SE
    Product Code
    OLO
    UDI-DI
    04056481143954
    PMA / PMN Number
    K221618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 6 SPINE SCREWS WERE PLACED IN THE PATIENT'S SPINE IN A DIFFERENT POSITION THAN DESIRED WITH BRAINLAB NAVIGATION INVOLVED, ALTHOUGH ACCORDING TO THE LIMITED INFORMATION FROM THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF 6 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY AND WERE CORRECTED TO THEIR INTENDED POSITION WITHOUT NAVIGATION AT THE VERY SAME SURGERY. - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT REPORTED DUE TO THE INITIAL DEVIATING SCREW PLACEMENTS, NEITHER DUE TO THE PROLONGED ANESTHESIA OF 45-60 MINUTES, - NO REMEDIAL ACTIONS FOR THE PATIENT WERE REPORTED THAT WOULD HAVE BEEN DONE, NECESSARY OR PLANNED, NOR WAS PROLONGATION OF HOSPITALIZATION REPORTED. 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. H6 ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE LIMITED INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF SIX SCREWS PLACED WITH AID OF NAVIGATION DEVIATING FROM THEIR INTENDED PLACEMENT IS: - MOVEMENTS OF THE NAVIGATION REFERENCE ARRAY DURING THE PROCEDURE IN RELATION TO THE PATIENT ANATOMY, DUE TO AN INSUFFICIENT RIGID FIXATION BY THE USER, NOT AS REQUIRED BY BRAINLAB. IMAGE DATA PROVIDED FOR THIS SURGERY SHOW THAT THE NAVIGATION REFERENCE ARRAY WAS FIXATED BETWEEN THE L2 AND L3 SPINOUS PROCESSES, NOT ENGAGED TO BONE, AND NOT ENSURING A RIGID FIXATION TO THE PATIENT ANATOMY. THIS CAUSED THE ARRAY TO BE PRONE TO INADVERTENT MOVEMENTS DUE TO ANY FORCES APPLIED TO THE PATIENT DURING INSTRUMENTATION, ALSO E.G. BY EVEN SLIGHT SURROUNDING SKIN PUSH/PULL FROM FORCES APPLIED TO THE SPINE AREA OPERATED ON. AS PER THE LOG FILES PROVIDED OF THIS SURGERY, THE NAVIGATION SOFTWARE DISPLAYED NAVIGATION REFERENCE ARRAY MOVEMENT WARNINGS TO THE USER DURING THE SURGERY, AT THE TIME OF INSTRUMENTING BOTH THE LEFT SIDE AND AGAIN ON THE RIGHT SIDE, INDICATING THE OCCURRENCE OF ARRAY MOVEMENT. THE NAVIGATION ACCURACY WAS CORRESPONDINGLY CHECKED BY THE USER AFTER THE WARNINGS, AS ANATOMY POINT ACQUISITIONS IN THE LOG FILES SHOW, AND APPARENTLY THE ACCURACY WAS STILL DEEMED ACCEPTABLE BY THE USER TO PROCEED. MOVEMENT OF THE REFERENCE ARRAY AFTER PATIENT REGISTRATION TO NAVIGATION DISRUPTS THE COORDINATE SYSTEM ESTABLISHED DURING THE REGISTRATION AND CAUSES A DEVIATION BETWEEN THE DISPLAYED IMAGE SCAN, ON WHICH THE NAVIGATED INSTRUMENTS ARE TRACKED, AND THE ACTUAL PATIENT ANATOMY. THIS MOVEMENT CANNOT BE COMPENSATED BY THE NAVIGATION SOFTWARE. - A DE-CALIBRATED SCANNER THAT WAS USED TO ACQUIRE THE PRE-PLACEMENT PATIENT SCANS WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION. TEST SCANS PERFORMED BY A BRAINLAB REPRESENTATIVE AFTER THE PROCEDURE REVEALED A DEVIATION OF THE ANATOMY REGISTRATION TO NAVIGATION WITH VALUES RANGING FROM 5.7 - 7.3 MM ON THE SIDE USED FOR THE PROCEDURE, INDICATING THAT THE SCANNER BECAME OUT OF CALIBRATION BEFORE THE SURGERY. A SCANNER THAT LOSES ITS CALIBRATION DUE TO, E.G. MECHANICAL FORCES FROM TRANSPORTATION INSIDE THE USER FACILITY SUCH AS THE EVENTS CAUSING THE DENTING TO THE DETECTOR AND SCANNER DISCOVERED DURING HARDWARE CHECKS AFTER THIS CASE, RESULTS IN AN INACCURATE ANATOMY REGISTRATION RESULT IN THE NAVIGATION. FURTHER CONTRIBUTING FACTORS ARE: - THE DISPOSABLE REFLECTIVE MARKER SPHERES USED IN THIS PROCEDURE WERE RE-USED, STERILIZED MARKER SPHERES THAT WERE PREVIOUSLY USED. NDI MARKER SPHERES ARE INTENDED FOR SINGLE-USE AND SHOULD NOT BE STERILIZED AND RE-USED. THE EFFECTIVENESS OF RE-STERILIZATION OF MARKER SPHERES CANNOT BE GUARANTEED AND MAY BE HAZARDOUS. DAMAGE TO THE SPHERES CAN OCCUR DUE TO REPROCESSING, ULTIMATELY AFFECTING NAVIGATION ACCURACY. CONTRIBUTING TO THE DEVIATED PLACEMENT OF BILATERAL SCREWS AT L5: - RELATIVE MOVEMENTS OF THE SPINE ANATOMY DURING THE SURGERY BETWEEN THE VERTEBRA THE NAVIGATION REFERENCE ARRAY WAS FIXATED TO (L2/L3), AND THE VERTEBRAE OPERATED ON DUE TO AN INSUFFICIENTLY RIGID CONNECTION OF THE ANATOMY IN BETWEEN, AND THE FORCES APPLIED TO THE BONE DURING INSTRUMENTATION. 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 - RESULTS 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. APPARENTLY, THE RESULTING DEVIATION OF THE INSTRUMENT LOCATIONS DISPLAY 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 LUMBAR SPINE FOR FUSION OF VERTEBRAE (L2-L5), WITH INTENDED PLACEMENT OF 6 BILATERAL SCREWS WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE 2D SCAN, THE SURGEON DISCOVERED THE 6 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED FROM THEIR INTENDED POSITIONS. THE DEVIATING SCREWS WERE REMOVED AND RE-PLACED TO THEIR INTENDED POSITIONS CONVENTIONALLY WITHOUT NAVIGATION AT THE VERY SAME SURGERY. ACCORDING TO THE LIMITED INFORMATION FROM THE HOSPITAL/SURGEON (TREATING CLINICIAN): - THE DEVIATION OF 6 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY AND WERE CORRECTED TO THEIR INTENDED POSITION WITHOUT NAVIGATION AT THE VERY SAME SURGERY. - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT REPORTED DUE TO THE INITIAL DEVIATING SCREW PLACEMENTS, NEITHER DUE TO THE PROLONGED ANESTHESIA OF 45-60 MINUTES. - NO REMEDIAL ACTIONS FOR THE PATIENT WERE REPORTED THAT WOULD HAVE BEEN DONE, NECESSARY OR PLANNED, NOR WAS PROLONGATION OF HOSPITALIZATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242375 SPINE & TRAUMA NAVIGATION 2.0. IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC OLO BRAINLAB SE 22268-04 04056481143954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other