BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTURA

    MDR report key: 22087557 · Received May 27, 2025

    Report

    Report Number
    3015941638-2025-00004
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    November 5, 2024
    Report Date
    May 5, 2025
    Manufacturer
    ASTURA MEDICAL
    Product Code
    NKB
    UDI-DI
    00841379176688
    PMA / PMN Number
    K182239
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SET SCREW WAS BACKING OUT RESULTING IN A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333457 ASTURA SET SCREW NKB ASTURA MEDICAL ABBA00000 723309A 00841379176688

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention