BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOQTEQ HTO PLATE

    MDR report key: 4213135 · Received September 4, 2014

    Report

    Report Number
    8043862-2014-00011
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 4, 2014
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K131782
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION. DUE TO A PSEUDARTHROSIS THE EXPECTED BONE HEALING DID NOT OCCUR. THEREFORE, THE SCREW PLATE CONSTRUCTION HAD TO BEAR THE FULL LOAD OF THE PATIENT WHO HAS A WEIGHT OF 130 KGS. AS A RESULT THE THREE SCREWS FAILED CAUSED BY PERMANENT LOAD. THE PRINCIPLE OF OSTEOSYNTHESIS IS TO SUPPORT THE BONE HEALING. WITHOUT ANY BONE HEALING A FAILURE OF PLATES OR SCREWS IS A COMMON SCENARIO AND RELATED TO THE PRODUCT ITSELF.

    Description of Event or Problem · 1

    APPROX 4 MONTH AFTER A HIGH TIBIA OSTEOTOMY SURGERY AN IMPLANT FAILURE WAS DETECTED BY THE SURGEON. THREE LOCKING SCREWS SHEARED OFF. SK 4526-50-2 LOTCODE K018 2 SCREWS. SK 4526-70-2 LOTCODE K021 1 SCREW. THE SURGEON MADE A REVISION SURGERY WITH A COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541412 LOQTEQ HTO PLATE BONE PLATE HRS AAP IMPLANTATE AG I009

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention