BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTURA

    MDR report key: 22893602 · Received August 26, 2025

    Report

    Report Number
    3015941638-2025-00006
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    June 11, 2025
    Report Date
    August 25, 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. IMPLANT WAS NOT BROKEN AND WAS STILL INTACT IN THE PATIENT.

    Description of Event or Problem · 0

    IMPLANT BACKED OUT REQUIRING A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2608548 ASTURA LLIF SPACER OVD ASTURA MEDICAL GB225510B 417115B 00840085225208

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention