BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOQTEQ® BROAD PLATE 4.5, 10 HOLES, L 186

    MDR report key: 15697559 · Received October 30, 2022

    Report

    Report Number
    3001406084-2020-00010
    Event Type
    Injury
    Date Received
    October 30, 2022
    Date of Event
    September 29, 2019
    Report Date
    September 1, 2020
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K113648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE PLATE WAS APPLIED ANTERIORLY TO THE FEMUR AFTER A PREVIOUS TRAUMA TREATMENT, PRESUMABLY AS A REVISION. THE TREATMENT FROM ANTERIOR LEADS TO AN ABOVE-AVERAGE BENDING LOAD AND HIGH DEFORMATION OF THE PLATE. IT ALSO RAISES THE QUESTION OF THE TYPE AND AMOUNT OF MOBILIZATION AS EARLY AS 14 DAYS POST-OP. INSPECTION OF THE AVAILABLE MANUFACTURING DOCUMENTATION (DHR) SHOWS NO DISCREPANCIES. THE MATERIAL AND FRACTURE ANALYSIS COULD NOT IDENTIFY ANY IMPLANT-ASSOCIATED CAUSE OF FAILURE. AS EXPECTED, THE FRACTURE WAS DETECTED AT THE POINT OF HIGHEST STRESS, THE CONNECTION OF PLATE TO SCREW. THE PRESENT FRACTURE IS A COMMON SHRINKAGE FRACTURE WITH SUBSEQUENT FORCE FRACTURE OF THE OVERLOADED RESIDUAL SURFACE. AN INCLUSION FOUND IN THE VICINITY COULD BE CLEARLY EXCLUDED AS THE CAUSE. FINALLY, THE ONLY POSSIBLE CAUSE IS EARLY MOBILIZATION, WHICH LED TO EARLY OVERLOADING (LOW CYCLE FATIGUE) OF THE PLATE IMPLANT. THIS IS A LATE REPORT DUE TO A CAPA ACTION.

    Description of Event or Problem · 0

    ONE OF THE PLATES - PG 4556 -10-2 WAS IMPLANTED IN AN 30 YEARS OLD MALE 110 KGS WITH TIBIA SHAFT FRACTURE. AFTER 15 DAYS, THE PATIENT PRESENTED WITH BROKEN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703719 LOQTEQ® BROAD PLATE 4.5, 10 HOLES, L 186 BONE PLATES HRS AAP IMPLANTATE AG PG 4556-10-2 K133

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Required Intervention