BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCALL

    MDR report key: 18294839 · Received December 8, 2023

    Report

    Report Number
    3012086398-2023-00002
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    September 25, 2023
    Report Date
    December 8, 2023
    Manufacturer
    BODYCAD LABORATORIES INC
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN A COMPLEX MEDIAL CLOSING WEDGE DISTAL FEMORAL OSTEOTOMY WITH AXIAL ROTATION, A CUSTOM-MADE BODYCAD FIXATION PLATE WAS USED. HOWEVER, DURING A POST-OPERATIVE CONTROL CHECK, SIGNIFICANT COMPLICATIONS WERE IDENTIFIED WITH THE PLATE. THE PLATE HAD FRACTURED, COMPROMISING THE STABILITY OF THE OSTEOTOMY. ADDITIONALLY, THERE WAS AN ISSUE OF SCREW MIGRATION, WHICH POSED A RISK TO THE STRUCTURAL INTEGRITY OF THE FIXATION AND COULD POTENTIALLY LEAD TO FURTHER COMPLICATIONS. AS A RESULT, AN REVISION SURGERY WAS PERFORMED USING A TRAUMA KIT TO ADDRESS THE FRACTURED PLATE AND MIGRATED SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780109 ONCALL ONCALL HRS BODYCAD LABORATORIES INC 012-000

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Required Intervention