BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOQTEQ® RECONSTRUCTION PLATE 3.5, 7 HOLES, L 82

    MDR report key: 18788019 · Received February 27, 2024

    Report

    Report Number
    3001406084-2024-00001
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    January 9, 2024
    Report Date
    February 8, 2024
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K113652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    505

    Narratives

    Description of Event or Problem · 0

    A RECONSTRUCTION PLATE WAS USED TO TREAT A MID-SHAFT FRACTURE OF THE RADIUS. THE PLATE BROKE 3.5 MONTHS AFTER TREATMENT DUE TO A FALL DURING A SPORTING ACTIVITY (SOCCER). THE PATIENT WAS TREATED IN REVISION SURGERY AND THE OSTEOSYNTHESIS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110022 LOQTEQ® RECONSTRUCTION PLATE 3.5, 7 HOLES, L 82 BONE PLATES HRS AAP IMPLANTATE AG PR 3550-07-2 T024

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Required Intervention