BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIUS GPS

    MDR report key: 21263192 · Received January 29, 2025

    Report

    Report Number
    3004142400-2024-00326
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    May 24, 2022
    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. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE ACCOUNT ON EVALUATED THE SYSTEM. THE FSE FOUND THAT THE ROLL AXIS WAS OUT OF HOMING AND SOFTWARE ENGINEER ASSISTED IN CORRECTING. GPS MOTION TESTS COMPLETED INCLUDING REDA FORCED HOMING, LOAD CELL CALIBRATION, AND ACCURACY TESTING WHICH ALL PASSED. FSE REHOMED THE SYSTEM AND NO FURTHER ACTION WAS REQUIRED AS SYSTEM WAS FULLY OPERATIONAL. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH DOES MATCH THE ANTICIPATED RISK LEVEL. THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE.

    Description of Event or Problem · 0

    CASE WAS T10-PELVIS. INTRA-OP WORKFLOW. FIRST TWO REGISTRATIONS (L2-S2 AND S2) WENT VERY SMOOTH WITH NO ISSUES. THIRD SPIN WAS T10-L1. SURGEON PLACED SCREWS T10-T12L. WHEN TRYING TO MOVE THE EE CLOSER TO THE ANATOMY THE ARM WOULD NOT ADVANCE WHEN SURGEON BRACELET WAS ENGAGED. THEN WHEN THE SURGEON TRIED TO RESETTLE THE ARM ONTO TRAJECTORY BY USING THE FOOT PEDAL THE ARM DRIFTED INFERIOR AND DID NOT COME BACK ON TRAJECTORY. I CHECKED THE LOADCELL AND ALL VALUES WERE STEADY AT 0. WE REMOVED THE EE AND ADJUSTED THE DRAPE THEN REPLACED THE EE. TRIED TO NAVIGATE TO A TRAJECTORY AND THE ARM DRIFTED THE SAME WAY. I THEN TRIED A MOTION RESET THAT DID NOT WORK. I THEN TRIED A HARD SHUTDOWN AND THAT DID NOT WORK EITHER. THE SURGEON THEN FREEHANDED THE LAST THREE SCREWS. I REMOVED THE ROBOT FROM THE OR AND REHOMED THE ARM AND THAT SEEMED TO FIX IT BUT COULD NOT CONFIRM DUE TO NOT BEING ABLE TO NAVIGATE TO A TRAJECTORY WITH THE EE. PLEASE SEND AN FSE OUT TO CONFIRM THERE ARE NO HARDWARE ISSUES CAUSING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792597 EXCELSIUS GPS SYSTEM, EXCELSIUS GPS, 120V OLO GLOBUS MEDICAL, INC. 6143.1001 GPS-0332 00889095481297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other