BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOQTEQ® NARROW PLATE 4.5, 12 HOLES, L 216 TITANIUM

    MDR report key: 15677513 · Received October 26, 2022

    Report

    Report Number
    3001406084-2020-00024
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    August 7, 2020
    Report Date
    September 25, 2020
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K113648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT, THERE WERE NO DEVIATIONS FROM THE SPECIFICATION REQUIREMENTS (MATERIAL, DESIGN AND MANUFACTURING). CAUSE: THE SURGEON USED A VERY RIGID CONSTRUCT AND SCREWS IN THE FRACTURE ZONE. ACCORDING TO THE BIOMECHANICAL PRINCIPLES FOR LOCKED PLATING, SUCH DESIGNS HAVE A VERY HIGH RISK OF IMPLANT FAILURE. THE RADIOGRAPHS SHOW PLATE FAILURE IN THE FRACTURE ZONE AND ALMOST NO FRACTURE CONSOLIDATION, WHICH WAS OBVIOUSLY THE REASON FOR THE PLATE FRACTURE (SEE ALSO "PITFALLS AND LIMITATIONS OF LOCKING PLATES" BY JEAN-CHRISTOPHE BEL). A CAUSAL INVOLVEMENT OF THE IMPLANT CAN BE EXCLUDED. THIS IS A LATE REPORT DUE TO A CAPA.

    Description of Event or Problem · 0

    BROKEN BONE PLATE AFTER 2 MONTHS OF HUMERAL SHAFT FRACTURE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2453083 LOQTEQ® NARROW PLATE 4.5, 12 HOLES, L 216 TITANIUM BONE PLATE HRS AAP IMPLANTATE AG PG 4555-12-2 K138

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Required Intervention