BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCELSIUS GPS

    MDR report key: 23622185 · Received November 21, 2025

    Report

    Report Number
    3004142400-2025-00280
    Event Type
    Death
    Date Received
    November 21, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 21, 2025
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    OLO
    UDI-DI
    00889095481297
    PMA / PMN Number
    K171651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT WITH A THORACIC FRACTURE HAD UNDERGONE A PROCEDURE INVOLVING EXCELSIUSGPS TO NAVIGATE AND PLACE SCREWS. IT WAS ALSO REPORTED THAT POST-OPERATIVE IMAGING CONFIRMED THAT SCREWS WERE ACCURATE AND NO SCREWS WERE FOUND TO BE MISPLACED OR HAVE ANY CLINICAL DEFICIT. THE PATIENT UNFORTUNATELY PASSED AWAY THE NEXT DAY. HOWEVER, UPON REVIEW OF THE PROVIDED POST-OPERATIVE SCANS AND IMPLANT PLANS, IT WAS DETERMINED THAT THE INCIDENT HAD NO RELATION TO THE USAGE OF EXCELSIUSGPS FOR THIS PROCEDURE. ADDITIONALLY, A GLOBUS MEDICAL FIELD SERVICE ENGINEER WAS SENT OUT TO PERFORM AN ACCURACY AND SYSTEM CHECK ON THE GPS UNIT, WHICH PASSED ALL TESTS AND WAS LEFT FULLY FUNCTIONAL. ANY APPLICABLE PARTS WILL BE RETURNING TO THE METHUEN IMAGING, NAVIGATION & ROBOTICS (INR) SITE AND PROCESSED PER NONCONFORMANCE WORK INSTRUCTION. AS THE INCIDENT DID NOT HAVE RELATION TO THE USAGE OF EXCELSIUSGPS, THERE IS NO RISK RECONCILIATION TO BE PERFORMED FOR THIS CASE, AND NO ASSOCIATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT THE HOSPITAL THEIR ELDERLY PATIENT WITH A THORACIC FRACTURE. THE PATIENT WAS UNWELL AND EVEN HAD AN ISSUE DURING THE SURGERY. EGPS WAS USED WITH E3D AND ALL SCREWS WERE EXECUTED. UNFORTUNATELY THE NEXT DAY THE PATIENT PASSED AWAY. POST OP IMAGING CONFIRMS SCREWS WERE ACCURATE BUT THERE WERE QUESTIONS ABOUT THE ROBOTIC CASE. NO SCREWS WERE FOUND DEVIATED TO HAVE A CLINICAL DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2559730 EXCELSIUS GPS ROBOT, SURGICAL, NAVIGATION UNIT OLO GLOBUS MEDICAL, INC. 6143.1001 GPS-0428 00889095481297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death