BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINE OSTEOTOMY

    MDR report key: 23669374 · Received November 28, 2025

    Report

    Report Number
    3012086398-2025-00004
    Event Type
    Injury
    Date Received
    November 28, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 27, 2025
    Manufacturer
    BODYCAD LABORATORY INC.
    Product Code
    HRS
    UDI-DI
    00688346002317
    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 AFTER A FINE OSTEOTOMY PROCEDURE AND REQUIRED HOSPITAL READMISSION FOR A WASHOUT SURGERY. THERE IS CURRENTLY NO CONFIRMED EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE INFECTION. THE EVENT IS UNDER INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2400890 FINE OSTEOTOMY FINE OSTEOTOMY HRS BODYCAD LABORATORY INC. 015-410-007 00688346002317

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Unknown Other