BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 17390072 · Received July 25, 2023

    Report

    Report Number
    3006742481-2023-00013
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    June 26, 2023
    Report Date
    July 24, 2023
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    HRS
    UDI-DI
    00841506115399
    PMA / PMN Number
    K200538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE FOREARM PLATING SYSTEM (WHICH INCLUDES MIDSHAFT ULNA PLATES) STATES THE FOLLOWING: "THE SET IS TO BE USED ONLY WITH SKELETAL DYNAMICS INSTRUMENTS, IMPLANTS, AND ACCESSORIES." ACCESSORIES NOT PROVIDED BY SKELETAL DYNAMICS OR INDICATED FOR USE WITH THIS PLATE WERE IMPLANTED WITH THE DEVICE, WHICH MAY HAVE NEGATIVELY IMPACTED THE FRACTURE SITE. WITHOUT PROPER HEALING, THE PLATE FAILED AFTER 18 MONTHS.

    Description of Event or Problem · 0

    AN IMPLANTED MIDSHAFT ULNA PLATE BROKE 18 MONTHS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697947 SKELETAL DYNAMICS INC. MIDSHAFT ULNA PLATE HRS SKELETAL DYNAMICS INC. DM2010037 00841506115399

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention