BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTURA MEDICAL

    MDR report key: 19479889 · Received June 6, 2024

    Report

    Report Number
    3015941638-2024-00006
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 23, 2024
    Manufacturer
    ASTURA MEDICAL
    Product Code
    ODP
    UDI-DI
    00840085232626
    PMA / PMN Number
    K202065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE LOCKING MECHANISM BROKE POST SURGERY ALLOWING THE SCREW TO BEGIN BACKING OUT WHICH RESULTED IN A REVISION SURGERY TO CORRECT THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055033 ASTURA MEDICAL SPINAL HALF PLATE IMPLANT ODP ASTURA MEDICAL LDB000006 568306D 00840085232626

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention