BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AAP LOQTEQ* DISTAL MEDIAL TIBIAPLATE 3.5

    MDR report key: 16597581 · Received March 23, 2023

    Report

    Report Number
    3001406084-2023-00005
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    February 13, 2023
    Report Date
    March 23, 2023
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K113601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOR A SHAFT FRACTURE OF THE TIBIA A TIBIA PLATE 3.5 WAS USED. 3 MONTH AFTER IMPLANTATION THE PLATE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427429 AAP LOQTEQ* DISTAL MEDIAL TIBIAPLATE 3.5 SMALL FRAGMENT SET HRS AAP IMPLANTATE AG PA 3532-10-2 T007

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Hospitalization| R