BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 19101887 · Received April 12, 2024

    Report

    Report Number
    3006742481-2024-00007
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Date of Event
    March 14, 2024
    Report Date
    April 11, 2024
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    HRS
    UDI-DI
    00841506102917
    PMA / PMN Number
    K140372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE PROTEAN FRAGMENT PLATE SYSTEM INCLUDES THE RELEVANT PRECAUTION: "THE FRAGMENT PLATE SYSTEM IS TO BE USED ONLY WITH SKELETAL DYNAMICS INSTRUMENTS, IMPLANTS AND ACCESSORIES." THE DECISION TO USE THIRD PARTY INSTRUMENTATION LIKELY NEGATIVELY IMPACTED THE APPROPRIATE DRILL TRAJECTORIES FOR THE PLATES, UNNECESSARILY STRESSING BOTH THE SCREWS AND THE PLATES.

    Description of Event or Problem · 0

    TWO IMPLANTED PROTEAN FRAGMENT PLATES AND THE SCREWS HOLDING THEM IN PLACE BROKE THREE MONTHS FOLLOWING INITIAL IMPLANTATION, REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836465 SKELETAL DYNAMICS INC. PROTEAN FRAGMENT PLATE (DOUBLE HOCKEY STICK, CENTRAL COLUMN PLATE) HRS SKELETAL DYNAMICS INC. 00841506102917

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention