BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE &TRAUMA NAVIGATION 2.0

    MDR report key: 23231877 · Received October 7, 2025

    Report

    Report Number
    8043933-2025-00067
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 7, 2025
    Manufacturer
    BRAINLAB SE
    Product Code
    OLO
    PMA / PMN Number
    K221618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    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 AND K-WIRES 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 THE (TEMPORARY) SPINE K-WIRES WAS DETECTED BY THE SURGEON WITH INTRAOPERATIVE C-ARM IMAGING, AND THEIR POSITIONS WHERE NECESSARY WERE CORRECTED AT THE VERY SAME SURGERY, BEFORE PLACING THEIR FOLLOWING SPINE SCREWS UNDER THEIR GUIDANCE. ALL SPINE SCREW PLACEMENTS WERE CORRECT AT THE END OF THE SURGERY - WHEREAS OTHER THAN ORIGINALLY INTENDED ONLY ONE PLIF CAGE WAS PLACED DUE TO PATIENT ACCESSIBILITY ISSUES, WHICH IS UNRELATED TO THE BRAINLAB NAVIGATION OR ITS USE. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING DUE TO THE DEVIATING INITIAL K-WIRE PLACEMENTS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 30-60MIN. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS ALSO NOT PROLONGED. H6: ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE ROOT CAUSE FOR THE INITIAL (TEMPORARY) K-WIRES PLACED WITH THE AID OF NAVIGATION BILATERAL IN VERTEBRAE L5 AND S1 DEVIATING BY CA. 4MM SHIFTED CAUDALLY, IS: A DE-CALIBRATED, AND THEREFORE INACCURATE, NON-BRAINLAB C-ARM THAT WAS USED TO ACQUIRE THE PATIENT IMAGE SCANS WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO NAVIGATION, IN COMBINATION WITH CONTINUEDLY REUSED MARKER SPHERES ON THE C-ARM REFERENCE ARRAY AGAINST BRAINLAB INSTRUCTIONS, NO LONGER BEING IN THE REQUIRED GOOD CONDITION FOR ACCURATE IMAGE REGISTRATION. TEST SCANS WITH THIS NON-BRAINLAB C-ARM PERFORMED BY A C-ARM MANUFACTURER'S REPRESENTATIVE AND A BRAINLAB REPRESENTATIVE AFTER THE PROCEDURE REVEALED A CALIBRATION DEVIATION OF THE C-ARM. A C-ARM THAT LOSES ITS CALIBRATION (DUE TO E.G. HIGH MECHANICAL FORCES AT TRANSPORTATION OR STORAGE INSIDE THE USER FACILITY) RESULTS IN AN INACCURATE ANATOMY REGISTRATION TO THE NAVIGATION. THE INACCURATE ANATOMY REGISTRATION FROM THE DE-CALIBRATED C-ARM, FURTHER CONTRIBUTED TO BY THE C-ARM ARRAY MARKER SPHERES NO LONGER BEING IN THE REQUIRED GOOD CONDITION, EXPLAINS THE CONSISTENTLY SHIFTED PLACEMENTS AND THE AFTER THE PLACEMENTS EVEN WITH A NEW REGISTERED SCAN OBSERVED CONSISTENT AND MATCHING DEVIATION OF THE NAVIGATED INSTRUMENTS AT THIS SURGERY. APPARENTLY, THE RESULTING DEVIATION BETWEEN THE ACTUAL PATIENT ANATOMY LOCATION DURING THE AFFECTED (INITIAL) PLACEMENTS AND THE REGISTERED PRE-PLACEMENT PATIENT SCAN DISPLAYED BY THE NAVIGATION FOR INSTRUMENT POSITION VISUALIZATION, WAS NOT RECOGNIZED BY THE USER WITH THE NECESSARY NAVIGATION ACCURACY VERIFICATION OF THE REGISTRATION, AND THROUGHOUT THE SURGERY BEFORE AND DURING PERFORMING SIGNIFICANT INVASIVE ACTIONS. 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 AND SACRAL SPINE FOR A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) OF VERTEBRAE L5 AND S1, DUE TO SPONDYLOLISTHESIS, 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 K-WIRES THROUGH THE NAVIGATED DRILL GUIDE IN L5/S1, THE SURGEON DETERMINED FROM INTRAOPERATIVE C-ARM IMAGING, THAT THE K-WIRES DEVIATED FROM THEIR INTENDED POSITIONS SHIFTED BY CA. 4MM, WITH THE RIGHT L5 K-WIRE PLACED THROUGH THE FORAMEN. 3 OF THE DEVIATING K-WIRES - WITH ONE OF THE PLACEMENTS STILL BEING ACCEPTABLE - WERE REMOVED AND RE-PLACED TO THEIR CORRECT POSITIONS AT THE VERY SAME SURGERY UNDER ADDITIONAL FLUOROSCOPIC GUIDANCE, BEFORE PLACING THEIR FOLLOWING SPINE SCREWS GUIDED BY THE TEMPORARY K-WIRES. ACCORDING TO THE SURGEON (TREATING CLINICIAN): ALL SPINE SCREW PLACEMENTS WERE CORRECT AT THE END OF THE SURGERY. THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING DUE TO THE DEVIATING INITIAL K-WIRE PLACEMENTS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 30-60MIN. 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
    2746283 SPINE &TRAUMA NAVIGATION 2.0 IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC OLO BRAINLAB SE 22268-04 SW V. 2.0.1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other