BEUDAMED
    FDA Adverse Event Death Summary report: N

    CREO

    MDR report key: 23975742 · Received January 6, 2026

    Report

    Report Number
    3004142400-2026-00005
    Event Type
    Death
    Date Received
    January 6, 2026
    Date of Event
    December 2, 2025
    Report Date
    January 6, 2026
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    LXH
    UDI-DI
    00889095173376
    PMA / PMN Number
    K124058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PURPOSE OF THIS INVESTIGATION IS TO EVALUATE THE REPORTED ISSUE OF: DEATH. THE PART WAS NOT RETURNED SO IT IS NOT POSSIBLE TO VERIFY THE REPORTED ISSUE. THE REPORTED MALFUNCTION OF THE GEARED REDUCER, THREADED DURING SURGERY. THE REDUCER ENGAGED WITH THE TULIP, BUT THE SET SCREW FAILED TO THREAD INTO THE TULIP. NO NEW INFORMATION UNCOVERED; CONFIRMED ISSUE WAS RESOLVED AND CONSTRUCT WAS LOCKED DOWN. PASSED AWAY 5 DAYS POST-SURGERY: CAUSE CURRENTLY UNKNOWN. MATCHES SYSTEM RISK ANALYSIS HAZARD: INSTRUMENT BINDS WHEN REDUCING. OBSERVED RISK LEVEL ALIGNS WITH EXPECTED RISK LEVEL. OVERALL SYSTEM RISK REMAINS MAINTAINED AND THERE IS NO FURTHER INVESTIGATION REQUIRED.

    Description of Event or Problem · 0

    T WAS REPORTED THAT THESE PARTS WOULD ENGAGE WITH TULIP, BUT THE SET SCREW WOULD NOT THREAD INTO THE TULIP. WHEN THE REDUCERS WERE ON THE TULIP & FULLY REDUCED ROD. THIS ADDED AN EXTRA 45 MIN TO SURGERY AS THEY TROUBLESHOOTED THE ISSUES, ULTIMATELY RESOLVED BY SWITCHING TO NEW INSTRUMENTATION. THE PATIENT PASSED AWAY AT THE HOSPITAL 5 DAYS LATER, THE SURGEON BELIEVES THE PATIENT HAD PROPOSAL INFUSION SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33482 CREO SURGICAL SCREWDRIVER, REUSABLE LXH GLOBUS MEDICAL, INC. 6120.2010 DIV102AF 00889095173376

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown Death| O