BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTURA MEDICAL

    MDR report key: 18676594 · Received February 9, 2024

    Report

    Report Number
    3015941638-2024-00001
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    January 4, 2024
    Report Date
    February 8, 2024
    Manufacturer
    ASTURA MEDICAL
    Product Code
    OSH
    UDI-DI
    00841379131212
    PMA / PMN Number
    K153446
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THREE SET SCREWS BACKED OUT REQUIRING A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52130 ASTURA MEDICAL SET SCREW OSH ASTURA MEDICAL ABAA00055 684907H 00841379131212

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention AADA65055 CORTICAL POLYAXIAL SCREW 6.5MM X 55MM