BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE & TRAUMA NAVIGATION 2.0.

    MDR report key: 23267531 · Received October 10, 2025

    Report

    Report Number
    8043933-2025-00070
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 10, 2025
    Manufacturer
    BRAINLAB SE
    Product Code
    OLO
    PMA / PMN Number
    K221618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 SPINE SCREWS WERE PLACED IN THE PATIENT'S SPINE IN A DIFFERENT POSITION THAN DESIRED WITH NAVIGATION INVOLVED, DESPITE ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF 3 OF THE 4 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION WERE DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND THE SCREWS WERE CORRECTED TO THEIR INTENDED POSITION WITHOUT NAVIGATION AT THE VERY SAME SURGERY. - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL SCREW PLACEMENTS CORRECTED 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 NEITHER HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING SCREWS PLACEMENTS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 120 MINUTES. - THERE WERE NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER. H6 ACCORDING TO THE RESULTS OF THE BRAINLAB TECHNICAL INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF THE DEVIATED SCREWS PLACED IN VERTEBRA AT BILATERAL L4 AND LEFT L5 WITH THE AID OF NAVIGATION IS: - RELATIVE MOVEMENTS OF THE SPINE ANATOMY DURING THE SURGERY BETWEEN THE INSTRUMENTED VERTEBRA (L4 AND L5) AND THE NAVIGATION REFERENCE ARRAY FIXATED TO LEFT ILIAC CREST, DUE TO AN INSUFFICIENTLY RIGID CONNECTION OF THE ANATOMY IN BETWEEN, AND THE FORCES APPLIED TO THE BONE DURING INSTRUMENTATION. SPECIFICALLY, THE FORCES PLACED BY HAMMERING THE SCREWDRIVER INTO PLACE. IN THIS CASE, A SHIFT IN THE ANATOMY AT L4 AND L5 IS OBSERVED UPON FUSING THE IMAGES WITH REGION OF INTEREST AT REFERENCE FIXATION . 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. TO A LESSER EXTENT: -MOVEMENT OF THE NAVIGATION REFERENCE ARRAY DUE TO INADVERTENT FORCES (SKIN PRESSURE/REBOUND) APPLIED TO THE FIXATION PINS AFTER REGISTRATION BUT DURING SCREW PLACEMENTS. MOVEMENT OF THE REFERENCE ARRAY DISRUPTS THE COORDINATE SYSTEM ESTABLISHED DURING PATIENT REGISTRATION AND CAUSES A DEVIATION BETWEEN THE PRE-PLACEMENT SCAN ON WHICH NAVIGATED INSTRUMENTS ARE TRACKED AND THE ACTUAL PATIENT ANATOMY. IN THIS CASE, ARRAY MOVEMENT WARNINGS WERE PRESENTED DURING SCREWDRIVER NAVIGATION AFTER TRAJECTORIES WERE STORED WITH THE POINTER. MANIPULATION OF THE SCREWDRIVER AGAINST THE SKIN TO MAINTAIN ALIGNMENT TO THE POINTER BASED TRAJECTORY COULD CAUSE A REBOUND PRESSURE ON THE REFERENCE FIXATION, THUS SHIFTING THE REFERENCE ARRAY DURING SCREWDRIVER NAVIGATION. APPARENTLY, THE RESULTING DEVIATION BETWEEN THE LOCATIONS OF THE ACTUAL PATIENT ANATOMY AND THE REGISTERED PRE-PLACEMENT PATIENT IMAGE SCAN DISPLAYED BY THE NAVIGATION AND INSTRUMENT LOCATION DISPLAYED, WAS NOT RECOGNIZED BY THE USER WITH THE APPROPRIATE AND NECESSARY NAVIGATION ACCURACY VERIFICATION THROUGHOUT THE SURGERY. 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

    A MINIMALLY INVASIVE SURGERY, ON THE LUMBAR SPINE FOR A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) OF VERTEBRAE L4 AND L5, DUE TO ARTHRODESIS, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 2.0. AFTER PLACING THE 4 SCREWS, THE SURGEON DETERMINED FROM INTRAOPERATIVE LOOP-X SCAN, THAT 3 SCREWS DEVIATED FROM THEIR INTENDED POSITIONS. THE 3 DEVIATING SCREWS WERE REMOVED AND RE-PLACED TO THEIR CORRECT POSITIONS AT THE VERY SAME SURGERY UNDER FLUOROSCOPIC GUIDANCE. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF 3 OF THE 4 SPINE SCREWS PLACED WITH THE AID OF NAVIGATION WERE DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND THE SCREWS WERE CORRECTED TO THEIR INTENDED POSITION WITHOUT NAVIGATION AT THE VERY SAME SURGERY. - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL SCREW PLACEMENTS CORRECTED 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 NEITHER HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING SCREWS PLACEMENTS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 120 MINUTES. - THERE WERE NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112601 SPINE & TRAUMA NAVIGATION 2.0. IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC OLO BRAINLAB SE 22268-04

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other