BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIRION 2-HOLE LATERAL PLATE

    MDR report key: 17672733 · Received September 1, 2023

    Report

    Report Number
    3011764740-2023-00002
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    June 30, 2023
    Report Date
    September 1, 2023
    Manufacturer
    ASTURA MEDICAL
    Product Code
    KWQ
    UDI-DI
    00840085229312
    PMA / PMN Number
    K192006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE LOCKING MECHANISM FOR A SIRION 2-HOLE LATERAL PLATE SEPARATED ON THE SUPERIOR SCREW ALLOWING THE SCREW TO PARTIALLY BACK OUT. THIS REQUIRED A REVISION SURGERY TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713188 SIRION 2-HOLE LATERAL PLATE SPINAL FIXATION KWQ ASTURA MEDICAL GCDBAZZ08 391806B 00840085229312

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention