BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE & TRAUMA NAVIGATION 3.0

    MDR report key: 23289527 · Received October 15, 2025

    Report

    Report Number
    8043933-2025-00073
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 14, 2025
    Manufacturer
    BRAINLAB SE
    Product Code
    OLO
    UDI-DI
    04056481144906
    PMA / PMN Number
    K221618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 SCREWS (AND ONE TEMPORARY K-WIRE) WERE PLACED IN THE PATIENT'S SPINE IN A DIFFERENT POSITION THAN DESIRED WITH BRAINLAB NAVIGATION INVOLVED, DESPITE ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATIONS OF THE SPINE SCREWS PLACED WERE DETECTED BY THE SURGEONS WITH INTRA-OPERATIVE X-RAYS BEFORE FINALIZING THE SURGERY, AND 4 OF THE SCREWS WERE CORRECTED TO THEIR INTENDED POSITIONS AT THE VERY SAME SURGERY WITH CONVENTIONAL METHODS. - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL SCREW PLACEMENTS CORRECT/ACCEPTABLE AT THE END OF THE SURGERY. - THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THESE DEVIATING PLACEMENTS. - THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 110MIN. - THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER. H6: ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE MAIN ROOT CAUSE FOR THE INITIAL SPINE SCREW PLACEMENTS WITH THE AID OF NAVIGATION DEVIATING SHIFTED BY MAX. 5MM IN DIFFERENT DIRECTIONS FROM THEIR INTENDED POSITIONS, IS: - MOVEMENTS OF THE NAVIGATION REFERENCE ARRAY DURING THE SURGERY, AFTER REGISTERING THE PRE-PLACEMENT C-ARM SCAN TO THE NAVIGATION, AND BEFORE PERFORMING THE INVASIVE SURGICAL ACTIONS IN THE SPINE, DUE TO AN INSUFFICIENTLY RIGID FIXATION BY THE USER AND INADVERTENTLY NOT ACTUALLY ON BONE, I.E. NOT AS REQUIRED, CAUSING IT TO BE PRONE TO MOVEMENTS DUE TO ANY SURGICAL OR INADVERTENT FORCES APPLIED AT THE PROCEDURE. POST PLACEMENT IMAGING DATA OF THIS SURGERY SHOWS THE ARRAY HAS BEEN INADVERTENTLY PLACED MAINLY IN BETWEEN THE SPINOUS PROCESSES OF VERTEBRAE T6 AND T7, RATHER THAN INTENDEDLY ON THE BONE OF THE SPINOUS PROCESS. THE SPINOUS PROCESSES WERE ALSO REPORTED TO BE FRACTURED, FURTHER ADDING TO THE INSTABILITY OF THE ARRAY FIXATION. IN ADDITION, NAVIGATION DATA PROVIDED SHOW MULTIPLE ARRAY MOVEMENT WARNINGS WERE DISPLAYED BY THE NAVIGATION DURING THE SURGERY - ALTHOUGH THE USER CHECKED NAVIGATION ACCURACY AFTER THE WARNINGS, THESE WARNINGS DISPLAYED INDICATE THAT THESE ARRAY MOVEMENTS HAVE OCCURRED. 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 TO A LESSER EXTENT CONTRIBUTING FACTOR, ESPECIALLY FOR THE DEVIATED INITIAL PLACEMENTS AT T3 AND T4: - TEMPORARY MOVEMENTS OF THE SPINE ANATOMY OPERATED ON DURING THE SURGERY IN RELATION TO THE LOCATION THE NAVIGATION REFERENCE ARRAY WAS ATTACHED TO (BETWEEN VERTEBRAE T6&T7), DUE TO AN INSUFFICIENTLY RIGID CONNECTION OF THE ANATOMY IN BETWEEN, AND THE FORCES APPLIED TO THE BONE DURING INSTRUMENTATION. A FRACTURE OF VERTEBRAE T5 AND T6 WAS PRESENT, SIGNIFICANTLY REDUCING THE RIGIDITY OF THE SPINE ANATOMY. 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 BETWEEN THE LOCATIONS OF THE ACTUAL PATIENT ANATOMY AND THE REGISTERED PREPLACEMENT PATIENT IMAGE SCAN DISPLAYED BY THE NAVIGATION DURING THE SURGERY WAS NOT RECOGNIZED BY THE SURGEON WITH THE APPROPRIATE AND NECESSARY NAVIGATION ACCURACY VERIFICATION THROUGHOUT THE SURGERY, AND ANY TIME SIGNIFICANT FORCE WAS APPLIED TO THE BONE, AND ADDITIONALLY AFTER THE REFERENCE ARRAY MOVEMENT WARNINGS DISPLAYED, DESPITE THE SURGEON DID CHECK THE NAVIGATION ACCURACY FOLLOWING THE WARNINGS. 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 THORACIC SPINE FOR A FUSION OF VERTEBRAE T3 TO T8, DUE TO A FRACTURE OF T5 AND T6, WITH INTENDED PLACEMENT OF 8 VERTEBRA SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE & TRAUMA NAVIGATION 3.0. FROM INTRA-OPERATIVE X-RAYS, THE SURGEONS DETERMINED THAT THE SPINE SCREWS PLACED WITH THE AID OF NAVIGATION DEVIATED SHIFTED BY MAX. CA. 5MM IN DIFFERENT DIRECTIONS FROM THEIR INTENDED POSITIONS. 4 OF THE DEVIATING SPINE SCREWS WERE REMOVED AND RE-PLACED TO THEIR INTENDED POSITIONS WITH CONVENTIONAL METHODS AT THE VERY SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL SCREW PLACEMENTS CORRECT/ACCEPTABLE AT THE END OF THE SURGERY. - THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THESE DEVIATING PLACEMENTS. - THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 110MIN. - THERE WERE FURTHER NO 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
    2647118 SPINE & TRAUMA NAVIGATION 3.0 IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC OLO BRAINLAB SE 22268-04A SW V. 3.0.0 04056481144906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other