BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIUS GPS

    MDR report key: 23728465 · Received December 5, 2025

    Report

    Report Number
    3004142400-2025-00295
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 5, 2025
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    OLO
    UDI-DI
    00889095481297
    PMA / PMN Number
    K171651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. CASE LOGS WERE NOT PROVIDED, SO A FORMAL INVESTIGATION COULD NOT BE COMPLETED. HOWEVER, IT WAS REPORTED THAT THE SCREWS IN QUESTION WERE MISPLACED IN THE SAME DIRECTION. THIS IS INDICATIVE OF A REGISTRATION SHIFT OR DYNAMIC REFERENCE BASE (DRB) SHIFT. BOTH REGISTRATION AND DRB SHIFTS CAN RESULT IN A LOSS OF NAVIGATIONAL INTEGRITY. AFTER THE REGISTRATION HAS BEEN COMPLETED, IT IS RECOMMENDED TO PERFORM A LANDMARK CHECK OR VERIFICATION TO ENSURE THAT THE REGISTRATION WAS SUCCESSFULLY CALCULATED . USING THE NAVIGATED VERIFICATION PROBE, TOUCH AN ANATOMICAL LANDMARK AND VERIFY THAT THE CORRESPONDING LOCATION IS SHOWN ON THE SYSTEM MONITOR . ULTIMATELY, THE USER OPTED TO REPLACE THE IMPLANTS AT T10 AND T11-R BY RE-REGISTERING THE PATIENT INTRAOPERATIVELY USING EXCELSIUS3D AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT REPORTED. IT WAS REPORTED THAT SCREWS WERE MISPLACED AT T10, T11-R, AND T12. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED 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

    IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, T10-L2 OPEN FUSION INSTRAOP MERGE WITH E3D, T10/T11/T12 WERE ALL MEDIAL/LATERAL MISSED SCREWS, T12 RIGHT AND LUMBAR SCREWS WERE PERFECT. T10 BILATERAL AND T11 RIGHT WERE REMOVED AND REPLACED AFTER THE SECOND E3D SPIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2811177 EXCELSIUS GPS ROBOT, SURGICAL, NAVIGATION UNIT OLO GLOBUS MEDICAL, INC. 6143.1001 GPS-0537 00889095481297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other