BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOQTEQ RECONSTRUCTION PLATE 3.5

    MDR report key: 3340835 · Received August 23, 2013

    Report

    Report Number
    8043862-2013-00007
    Event Type
    Injury
    Date Received
    August 23, 2013
    Report Date
    August 23, 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 RETURNED BY THE USER AND WILL BE EVALUATED AS SOON AS POSSIBLE.

    Description of Event or Problem · 1

    A LOQTEQ RECONSTRUCTION PLATE 3.5 WITH 10-HOLES BROKE IN PATIENT. REVISION SURGERY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413866 LOQTEQ RECONSTRUCTION PLATE 3.5 BONE PLATE HRS AAP IMPLANTATE AG K025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention