BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTURA MEDICAL

    MDR report key: 22998657 · Received September 8, 2025

    Report

    Report Number
    3015941638-2025-00007
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    June 11, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ASTURA MEDICAL
    Product Code
    OVD
    UDI-DI
    00840085225208
    PMA / PMN Number
    K192006
    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

    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.

    Description of Event or Problem · 0

    IMPLANT BACKED OUT REQUIRING A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915763 ASTURA MEDICAL LLIF SPACER OVD ASTURA MEDICAL GB225510B 417115B 00840085225208

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Required Intervention