BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTURA CAGE INSERTER

    MDR report key: 20267110 · Received September 20, 2024

    Report

    Report Number
    20267110
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    June 16, 2024
    Report Date
    April 8, 2024
    Manufacturer
    ASTURA MEDICAL
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THUMB TIGHTENER PLATE ON ASTURA CAGE INSERTER WAS NOT FUNCTIONING PROPERLY DURING CASE AND REPORTEDLY FELT "STIFF" DURING USE, LATER WAS FOUND BROKEN OFF ON THE DRAPE. ASTURA REP PRESENT AND MADE AWARE, EQUIPMENT REMOVED FROM CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472053 ASTURA CAGE INSERTER ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ASTURA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male