BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINE OSTEOTOMY

    MDR report key: 23669236 · Received November 27, 2025

    Report

    Report Number
    3012086398-2025-00003
    Event Type
    Injury
    Date Received
    November 27, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 27, 2025
    Manufacturer
    BODYCAD LABORATORIES INC
    Product Code
    HRS
    UDI-DI
    00688346002287
    PMA / PMN Number
    K241356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT DEVELOPED A POSTOPERATIVE SURGICAL SITE INFECTION REQUIRING READMISSION AND A WASHOUT PROCEDURE AFTER THE USE OF A BODYCAD FINE OSTEOTOMY PATIENT-SPECIFIC PLATE. THERE IS NO CONFIRMED EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE INFECTION. THE EVENT IS UNDER INTERNAL INVESTIGATION, AND ADDITIONAL INFORMATION WILL BE PROVIDED AS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149704 FINE OSTEOTOMY FINE OSTEOTOMY HRS BODYCAD LABORATORIES INC 00688346002287

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Unknown Required Intervention