BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XL OLLIF INSERTER

    MDR report key: 22629784 · Received July 28, 2025

    Report

    Report Number
    MW5173406
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 23, 2025
    Report Date
    July 24, 2025
    Manufacturer
    ADVANCED RESEARCH MEDICAL LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING SURGICAL PROCEDURE, DR. (B)(6) WAS USING THE CAGE INSERTER FOR A REVISION OF A PREVIOUS CAGE (FUSION). DURING USE, THE TIP OF THE CAGE INSERTER GOT STUCK INSIDE THE CAGE AND BROKE OFF INSIDE THE IMPLANTED CAGE. UNABLE TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2663979 XL OLLIF INSERTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ADVANCED RESEARCH MEDICAL LLC A-00-2 REV A PF045AA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other