BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 22486265 · Received July 11, 2025

    Report

    Report Number
    3006742481-2025-00006
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 11, 2025
    Report Date
    July 10, 2025
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    HRS
    UDI-DI
    00841506102993
    PMA / PMN Number
    K111620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE GEMINUS® DISTAL RADIUS PLATING SYSTEM INCLUDES THE FOLLOWING WARNINGS: "ALL SCREWS MUST BE IMPLANTED AND FULLY TIGHTENED INTO THE PLATE TO MAINTAIN THE INTEGRITY AND STRENGTH OF THEFINISHED CONSTRUCT. IF THE SCREWS ARE NOT ATTACHED AND/OR FULLY TIGHTENED, A NON-UNION, DELAYED UNION OR CONSTRUCT FAILURE MAY OCCUR." "THE USE OF POWER TOOLS FOR THE INSTALLATION OF THE SCREWS AND PEGS IS NOT RECOMMENDED AND MAY LEAD TO CROSS THREADING AND DAMAGE TO THE SCREWS AND/OR PLATES." ALTHOUGH THE DEVICES HAVE NOT BEEN MADE AVAILABLE FOR ANALYSIS AT THIS TIME, LIKELY CAUSES OF FAILURE INCLUDE NOT FULLY TIGHTENING THE SCREWS OR DEVIATING FROM THE RECOMMENDED SURGICAL TECHNIQUE.

    Description of Event or Problem · 0

    TWO SMOOTH PEG LOCKING SCREWS BACKED OUT OF A PATIENT'S GEMINUS PLATE WITHIN ONE MONTH OF IMPLANTATION, REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949125 SKELETAL DYNAMICS INC. SMOOTH PEG, LOCKING, 2.00MM X 18MM, TI HRS SKELETAL DYNAMICS INC. 00841506102993

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention