BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE & TRAUMA NAVIGATION 2.0

    MDR report key: 23436925 · Received October 31, 2025

    Report

    Report Number
    8043933-2025-00078
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    October 4, 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
    GM
    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 (PILOT HOLES WERE CREATED AND) K-WIRES WERE PLACED IN THE PATIENT'S SPINE IN DIFFERENT POSITIONS THAN DESIRED WITH BRAINLAB NAVIGATION INVOLVED, ALTHOUGH ACCORDING TO THE HOSPITAL (PHYSICIAN, CLINICIAN): - THE DEVIATION OF 4 K-WIRES PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON WITH AN INTRA-OPERATIVE VERIFICATION CT SCAN, AND THE K-WIRES WERE CORRECTED TO THEIR INTENDED POSITIONS WITH NAVIGATION AT THE VERY SAME SURGERY, BEFORE PLACING THEIR SUBSEQUENT SPINE SCREWS. - THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL PLACEMENTS CORRECT AT THE END OF THE SURGERY - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE INITIAL DEVIATING PLACEMENTS, DESPITE A DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE, AND THERE WAS ALSO NO NEGATIVE EFFECT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF 27MIN - THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS ALSO NOT PROLONGED H6: ACCORDING TO THE RESULTS OF BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF FOUR K-WIRES PLACED WITH AID OF NAVIGATION FIRST IN A TOO FAR LATERALLY LEFT AND CRANIAL DIRECTION, FOLLOWED BY THEIR REPLACEMENT LATERALLY RIGHT, IS: - TEMPORARY 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 WITH ONLY SOME OF THE TEETH ENGAGED TO BONE AROUND THE T9 SPINOUS PROCESS, 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. 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. APPARENTLY, THE RESULTING DEVIATION BETWEEN THE REGISTERED PRE/INTRA-OPERATIVE IMAGE SCAN IN THE NAVIGATION DISPLAY AND THE ACTUAL PATIENT ANATOMY WAS NOT RECOGNIZED BY THE USER WITH THE APPROPRIATE AND NECESSARY ACCURACY VERIFICATION THROUGHOUT THE PROCEDURE, BEFORE AND DURING PERFORMING SIGNIFICANT INVASIVE ACTIONS WITH THE AID OF NAVIGATION. 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 PERCUTANEOUS STABILIZATION OF VERTEBRAE T4 AND T5, DUE TO SPONDYLARTHRITIS, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. FROM AN INTRA-OPERATIVE VERIFICATION CT SCAN, THE SURGEON DETERMINED THAT 4 K-WIRES PLACED WITH THE AID OF NAVIGATION AT T4 AND T5 DEVIATED BY CA. 4MM FROM THEIR INTENDED POSITIONS, WITH THE LEFT SIDE K-WIRES BEING PLACED INTO THE SPINAL CANAL. THE DEVIATING K-WIRES WERE REMOVED AND RE-PLACED TO THEIR INTENDED POSITIONS WITH NAVIGATION AT THE VERY SAME SURGERY, BEFORE PLACING THEIR SUBSEQUENT SPINE SCREWS. ACCORDING TO THE HOSPITAL (PHYSICIAN, CLINICIAN): - THE DEVIATION OF 4 K-WIRES PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON WITH AN INTRA-OPERATIVE VERIFICATION CT SCAN, AND THE K-WIRES WERE CORRECTED TO THEIR INTENDED POSITIONS WITH NAVIGATION AT THE VERY SAME SURGERY, BEFORE PLACING THEIR SUBSEQUENT SPINE SCREWS. - THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL PLACEMENTS CORRECT AT THE END OF THE SURGERY. - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE INITIAL DEVIATING PLACEMENTS, DESPITE A DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE, AND THERE WAS ALSO NO NEGATIVE EFFECT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF 27MIN. - THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS ALSO NOT PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562131 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