BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTURA MEDICAL

    MDR report key: 23295465 · Received October 15, 2025

    Report

    Report Number
    3015941638-2025-00011
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    November 18, 2024
    Report Date
    July 30, 2025
    Manufacturer
    ASTURA MEDICAL
    Product Code
    KWO
    UDI-DI
    00841379102380
    PMA / PMN Number
    K160702
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PERFORMANCE TESTING OF THE IMPLANTS SHOW THEY MEET OUR ESTABLISHED PERFORMANCE REQUIREMENTS.

    Description of Event or Problem · 0

    SCREW BACKED OUT OF PLATE REQUIRING A REVISION SURGERY. ASTURA WAS NOT NOTIFIED OF THIS UNTIL (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2536016 ASTURA MEDICAL ACP, 1 LEVEL, 14MM KWO ASTURA MEDICAL CA1000014 765801F 00841379102380

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention