BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLLIF INSERTER, INNER

    MDR report key: 20855160 · Received December 4, 2024

    Report

    Report Number
    MW5163233
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 27, 2024
    Report Date
    December 2, 2024
    Manufacturer
    ADVANCED RESEARCH MEDICAL, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TIP OF CAGE INSERTER BROKE OFF IN PATIENT. ALL PIECES LEFT IN PATIENT PER DR. DIRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290691 OLLIF INSERTER, INNER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ADVANCED RESEARCH MEDICAL, LLC 01-00-2 AC091AB

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other