BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOQTEQ RECONSTRUCTION PLATE 3.5

    MDR report key: 2930477 · Received January 21, 2013

    Report

    Report Number
    8043862-2013-00001
    Event Type
    Injury
    Date Received
    January 21, 2013
    Date of Event
    December 25, 2012
    Report Date
    January 18, 2013
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K113652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED TODAY AND WILL BE EVALUATED ASAP.

    Description of Event or Problem · 1

    A LOQTEQ RECONSTRUCTION PLATE 3.5 WITH 10-HOLES BROKE AROUND 4 WEEKS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28613 LOQTEQ RECONSTRUCTION PLATE 3.5 BONE PLATE HRS AAP IMPLANTATE AG

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention