BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIUS GPS

    MDR report key: 21263175 · Received January 29, 2025

    Report

    Report Number
    3004142400-2024-00500
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    August 22, 2023
    Report Date
    January 28, 2025
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    OLO
    UDI-DI
    00889095481297
    PMA / PMN Number
    K171651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS BEING REPORTED FOR A PROBLEM FOUND EARLIER. INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. DURING PLACEMENT OF THE SCREWS, THE SOFTWARE DETECTED EXCESSIVE FORCES ON THE END EFFECTOR LOAD CELL DURING BONE WORK. THIS IS THE RESULT OF SKIVING FORCES DETECTED WHILE A TOOL IS INSERTED INTO THE END EFFECTOR. SKIVING CAN LED TO THE MISPLACEMENT OF SCREWS. THE SOFTWARE CORRECTLY DETECTED THE FORCE AND ALERTED THE USER. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND THERE IS NO FURTHER INVESTIGATION REQUIRED. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE.

    Description of Event or Problem · 0

    THERE WAS AN INCIDENT DURING A CASE AT CONWAY MEDICAL CENTER YESTERDAY WHERE EGPS PLACED TWO SCREWS AT L3 USING E3D AND INTRAOPERATIVE WORKFLOW. BOTH SCREWS GOT A CHECK MARK ON THE ROBOT WHEN THEY WERE PLACED, BUT THE LEFT SCREW WAS SIGNIFICANTLY LATERAL TO THE PLAN AND THE RIGHT SCREW WAS SLIGHTLY INFERIOR. I'M NOT SURE IF THE LEFT SCREW WAS INFERIOR AS WELL BECAUSE IT WAS REMOVED BEFORE A LATERAL XRAY WAS TAKEN. THE LOCAL TEAM WANTED AN EEF FILED TO CHECK FOR ACCURACY ON THE SYSTEM AND THE CAMERA CALIBRATION. AFTER THE LEFT SCREW WAS REMOVED, WE DID A BAILOUT TO 2D NAVIGATION WITH E3D. THE SCREW FOLLOWED THE ORIGINAL SCREWS TRAJECTORY, WHICH WAS VISIBLE ON EGPS, AND THE SURGEON DECIDED TO BAIL ON NAVIGATION AND PLACE THE SCREW USING A K-WIRE AND FLUORO IMAGING. THE LOCAL TEAM ALSO WANTED TO NOTE THAT THE OFFSET METER HAS BEEN MUCH MORE SENSITIVE SINCE THE UPGRADE TO THE POINT WHERE IT'S ALMOST ALWAYS HIGH AND THEY ARE CONSISTENTLY LOSING THE GREEN BORDERS EVEN WHEN THE SCREW IS BEING PLACED ACCURATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791594 EXCELSIUS GPS SYSTEM, EXCELSIUS GPS, 120V OLO GLOBUS MEDICAL, INC. 6143.1001 GPS-0200 00889095481297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other