BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTURA

    MDR report key: 21608455 · Received March 14, 2025

    Report

    Report Number
    3015941638-2025-00003
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    January 23, 2025
    Report Date
    March 14, 2025
    Manufacturer
    ASTURA MEDICAL
    Product Code
    OVE
    UDI-DI
    00840085250705
    PMA / PMN Number
    K202065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A FOREIGN PART APPEARED ON THE CT SCAN. A REVISION SURGERY REPORTEDLY FOUND "A WIRE" WHICH WAS PRESUMBALY CAUSED BY SOME SHEERED THREADING FROM THE SCREW. THE ACTUAL IMPLANTS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926069 ASTURA PLATE OVE ASTURA MEDICAL LDD000006 620402A 00840085250705

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention