BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AAP LOQTEQ® DISTAL ANTEROLATERAL TIBIA PLATE 3.5

    MDR report key: 15968813 · Received December 13, 2022

    Report

    Report Number
    3001406084-2020-00023
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    November 10, 2018
    Report Date
    September 28, 2020
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K133675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION SHOWED THAT THE PLATE WAS MANUFACTURED AND USED ACCORDING TO SPECIFICATIONS/ INSTRUCTIONS. ACCORDING TO A CONSULTED PHYSICIAN, THE ADVERSE EVENT WAS MOST PROBABLY CAUSED BY THE COMPLEX FRACTURE WHICH MIGHT BE STRAINED TOO EARLY. THIS IS A LATE REPORT DUE TO A CORRECTIVE ACTION.

    Description of Event or Problem · 0

    APPROXIMATELY 3 MONTH AFTER THE IMPLANTATION A BROKEN TIBIA PLATE WAS REPLACED DURING REVISION. THE PLATE BROKE AT THE SAME HEIGHT AS THE BONE WAS FACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424650 AAP LOQTEQ® DISTAL ANTEROLATERAL TIBIA PLATE 3.5 DISTAL ANTEROLATERAL TIBIA PLATE HRS AAP IMPLANTATE AG PA 3522-12-2 I204

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention