BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINE OSTEOTOMY

    MDR report key: 21577300 · Received March 11, 2025

    Report

    Report Number
    3012086398-2025-00002
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 12, 2025
    Report Date
    March 11, 2025
    Manufacturer
    BODYCAD LABORATORIES, INC.
    Product Code
    HRS
    PMA / PMN Number
    K240703
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AT SIX MONTHS POST-OPERATIVE, THE X-RAY SHOWS A NON-UNION OF THE OSTEOTOMY. SCREW BACK-OUT IS OBSERVED, PARTICULARLY IN THE MOST PROXIMAL SCREW AND ONE OF THE FIRST SCREWS IN THE DISTAL CLUSTER, ALTHOUGH THE SCREWS APPEARED PROPERLY POSITIONED IN THE IMMEDIATE POST-OP IMAGING. THE OSTEOTOMY SEEMS TO HAVE BEEN PERFORMED IN THE CORRECT LOCATION, THOUGH THE CUT APPEARS SLIGHTLY SHALLOW. A REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368077 FINE OSTEOTOMY FINE OSTEOTOMY HRS BODYCAD LABORATORIES, INC. 015000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention