BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIUS GPS

    MDR report key: 21264882 · Received January 29, 2025

    Report

    Report Number
    3004142400-2024-00420
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    March 28, 2023
    Report Date
    January 29, 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. THIS ERROR GETS RAISED WHEN ONE OR MORE AXES ARE NOT IN STANDSTILL STATE WHEN TRYING TO START MOVEMENT. MOTION WAS LOST DURING THE CASE BECAUSE WHEN ANY AXIS IS IN AN ERROR STATE, ALL AXES ARE PREVENTED FROM MOVING. IMPROVEMENTS TO GMAS SOFTWARE WERE MADE TO ADDRESS THIS ISSUE IN THE SOFTWARE RELEASE FOLLOWING THIS INCIDENT. IN PARTICULAR, THE CODE THAT POWERS AXE OFF WAS MADE TO BE MORE ROBUST, ENSURING AXES WOULD UNDERGO THE CORRECT STATE TRANSITIONS. AS NOTED IN THE ATTACHED RISK RECONCILIATION FORM, THE OBSERVED RISK LEVEL IS LOW AND IS EQUAL TO THE ANTICIPATED RISK LEVEL . THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AS "LOW" AN NO FURTHER INVESTIGATION IS REQUIRED. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE.

    Description of Event or Problem · 0

    L4-5 INTRA-OP CASE. REGISTRATION NORMAL/NO ERRORS/NO SHIFTS. SCREW PLACEMENT: L4-R PLACED, SELECTED L5-R, PRESSED FOOT PEDAL, EE CAME OFF L4-R LIKE NORMAL. MOVED EE OUT OF WAY WITH RING. ADJUSTED L5-R PLAN, BACK TO NAVIGATE, PRESSED FOOT PEDAL, ARM FLOATED TO THE SIDE. THEN ARM LOCKED UP/WOULD NOT MOVE VIA BUTTONS, FOOT PEDAL, OR RING. ARM WOULD NOT MOVE, RE-HOME, OR RE-CALIBRATE LOADCELL AFTER MULTIPLE HARD SHUTDOWNS AND SOFTWARE RESETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047328 EXCELSIUS GPS SYSTEM, EXCELSIUS GPS, 120V OLO GLOBUS MEDICAL, INC. 6143.1001 GPS-0159 00889095481297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other