BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINE OSTEOTOMY

    MDR report key: 20540231 · Received October 26, 2024

    Report

    Report Number
    3012086398-2024-00001
    Event Type
    Malfunction
    Date Received
    October 26, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 24, 2024
    Manufacturer
    BODYCAD LABORATORIES, INC
    Product Code
    HRS
    UDI-DI
    00688346002287
    PMA / PMN Number
    K240703
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A HIGH TIBIAL OSTEOTOMY (HTO) WAS PERFORMED USING THE FINE OSTEOTOMY SYSTEM APPROXIMATELY 5 MONTHS AGO, RESULTING IN A NONUNION, INDICATING A LACK OF PROPER BONE HEALING. THE LIMB NOW SHOWS A VARUS DEVIATION, ALONG WITH HARDWARE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569091 FINE OSTEOTOMY FINE OSTEOTOMY HRS BODYCAD LABORATORIES, INC 015000 00688346002287

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention