BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINE OSTEOTOMY

    MDR report key: 24793545 · Received April 6, 2026

    Report

    Report Number
    3012086398-2026-00001
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    February 26, 2026
    Report Date
    April 6, 2026
    Manufacturer
    BODYCAD LABORATORIES, INC.
    Product Code
    HWC
    UDI-DI
    00688346002287
    PMA / PMN Number
    K253300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A HARDWARE REMOVAL PROCEDURE, TWO BONE SCREWS WERE FOUND TO BE FRACTURED. THE EVENT WAS IDENTIFIED INTRAOPERATIVELY DURING EXPLANTATION OF A PREVIOUSLY IMPLANTED SYSTEM. IMAGING PRIOR TO REMOVAL HAD NOT CLEARLY INDICATED BREAKAGE. SOME SCREW FRAGMENTS REMAINED IN SITU. THE PROCEDURE WAS OTHERWISE COMPLETED, AND THE PATIENT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855697 FINE OSTEOTOMY FINE OSTEOTOMY HWC BODYCAD LABORATORIES, INC. 015-000 00688346002287

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male