BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AAP LOQTEQ® VA RADIUS SET 2.5

    MDR report key: 15970340 · Received December 13, 2022

    Report

    Report Number
    3001406084-2020-00021
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    October 18, 2017
    Report Date
    September 28, 2020
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K153034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS FAR AS CAN BE DETERMINED, THE PRESENT PLATE WAS ALREADY USED AS A REVISION IMPLANT AFTER IMPLANT FRACTURE. THE USER DID NOT PROVIDE ANY INFORMATION ON THE INDICATION FOR THIS IMPLANT, EVEN UPON REQUEST. AT PRESENT IT CAN BE ASSUMED THAT THE PLATE WAS SUBOPTIMALLY SELECTED FOR THIS CLINICAL CASE. AN ALREADY FAILED OSTEOSYNTHESIS REPRESENTS A COMPLEX CLINICAL CASE. IN THESE CASES THE REVISION IMPLANT SHOULD BE SELECTED WITH THE GREATEST CARE. OFTEN IMPLANTS WITH LARGER SUPPORT OR DOUBLE PLATING ARE USED. IT IS NOT POSSIBLE TO DETERMINE WHY A PRIMARY IMPLANT WITHOUT ADDITIONAL SUPPORT WAS SELECTED IN THIS CASE ON THE BASIS OF THE INFORMATION PROVIDED. INFORMATION ON HOW THE FAILURE OF THE PRIMARY IMPLANT OCCURRED IS ALSO NOT AVAILABLE. OTHER FACTORS INFLUENCING THE HEALING PROCESS ARE ALSO NOT KNOWN. ALL IN ALL, ACCORDING TO AVAILABLE INFORMATION, AN INADEQUATE OSTEOSYNTHESIS AFTER REVISION IS ASSUMED. THIS IS A LATE REPORT DUE TO A CORRECTIVE ACTION.

    Description of Event or Problem · 0

    A LOQTEQ® VA RADIUS PLATE 2.5 WAS IMPLANTED INTO A 54 YEAR OLD PATIENT APPROXIMATELY ONE MONTH LATER THE PATIENT COMPLAINT ABOUT PAIN IN THE HAND WRIST. THE PLATE WAS FOUND BROKEN. A REVISION OPERATION NEED TO BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423765 AAP LOQTEQ® VA RADIUS SET 2.5 VARIABLE ANGLE DISTAL RADIUS/ULNA PLATES AND SCREWS 2.5 HRS AAP IMPLANTATE AG PR 2522-05-2 I057

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown Required Intervention