BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 19345202 · Received May 17, 2024

    Report

    Report Number
    3006742481-2024-00009
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    July 18, 2023
    Report Date
    May 15, 2024
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    HWC
    UDI-DI
    00841506103440
    PMA / PMN Number
    K182492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FAILURE WAS BROUGHT TO THE ATTENTION OF SKELETAL DYNAMICS NINE MONTHS AFTER THE EXPLANTATION DATE. NO INFORMATION PERTAINING TO PATIENT BEHAVIOR FOLLOWING INITIAL IMPLANTATION AND PRIOR TO THE BREAK WAS ABLE TO BE OBTAINED, NO IMAGES FROM THE ORIGINAL CASE NOR THE EXPLANTATION WERE PROVIDED, AND THE IMPLANT WAS NOT AVAILABLE FOR RETURN. THEREFORE, AT THIS TIME THE INVESTIGATION IS NECESSARILY LIMITED TO INTERNAL TESTING AND REVIEW OF RECORDS.

    Description of Event or Problem · 0

    A 2.3MM LOCKING THREADED PEG BROKE FOLLOWING IMPLANTATION OF A GEMINUS VOLAR DISTAL RADIUS PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919811 SKELETAL DYNAMICS INC. THREADED PEG, LOCKING, 2.3MM, TI HWC SKELETAL DYNAMICS INC. 00841506103440

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention