BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOQTEQ® OSTEOTOMY PLATE 4.5

    MDR report key: 23368834 · Received October 23, 2025

    Report

    Report Number
    3001406084-2025-00001
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 23, 2025
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K131782
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE OSTEOSYNTHESIS FAILURE CAN BE ATTRIBUTED TO A COMBINATION OF VARIOUS FACTORS. IT IS HIGHLY PROBABLE THAT A HINGE FRACTURE OCCURRED INITIALLY. THE OSTEOTOMY WAS PERFORMED VERY DISTALLY WITH A LARGE OSTEOTOMY WIDTH. THIS RESULTED IN PRIMARY INSTABILITY, WHICH IN ALL PROBABILITY LED TO DELAYED BONE HEALING. THE PLATE SYSTEM USED IS GENERALLY NOT DESIGNED FOR LONG-TERM SOLE LOAD TRANSFER WITHOUT BONY SUPPORT.

    Description of Event or Problem · 0

    LOSS OF CORRECTION ON THE LEFT KNEE AFTER DEVARICATING HTO 8.5 MONTHS POSTOPERATIVELY WITH RADIOLOGICALLY VISIBLE SCREW FRACTURE OF THE DISTAL 3 SCREWS ON THE TIBIA-HTO PLATE IN THE ABSENCE OF BONY HEALING OF THE OSTEOTOMY GAP AND SIGNS OF OCCULT HINGE-FX TAKEUCHI TYPE 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930421 LOQTEQ® OSTEOTOMY PLATE 4.5 BONE PLATES HRS AAP IMPLANTATE AG PO 4560-01-2 W030

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention