BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTURA MEDICAL

    MDR report key: 22287441 · Received June 18, 2025

    Report

    Report Number
    3015941638-2025-00005
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 18, 2025
    Manufacturer
    ASTURA MEDICAL
    Product Code
    NKB
    UDI-DI
    00840085257636
    PMA / PMN Number
    K231694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ITEMS FROM THE SAME LOT WERE TESTED AND WORK AS THEY SHOULD. ORIGINAL RECEIVING INSPECTION REPORTS SHOW IMPLANTS TO BE IN SPECIFICATION. TORQUE HANDLES WERE TESTED AND WITHIN OPERATIONAL CALIBRATION RANGE.

    Description of Event or Problem · 0

    SET SCREWS POPPED OUT CAUSING A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854415 ASTURA MEDICAL SET SCREW NKB ASTURA MEDICAL NCAA00000 715601B 00840085257636

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention