BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 19637858 · Received June 28, 2024

    Report

    Report Number
    3006742481-2024-00011
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    May 31, 2024
    Report Date
    June 27, 2024
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    OZI
    UDI-DI
    00841506104904
    PMA / PMN Number
    K153208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE IJS-E SYSTEM INCLUDES CONTRAINDICATIONS ADVISING AGAINST USE ON PATIENTS WHO ARE "UNWILLING OR INCAPABLE OF FOLLOWING POST OPERATIVE CARE INSTRUCTIONS." IT ALSO INCLUDES THE FOLLOWING WARNINGS AND PRECAUTIONS: "THE DEVICE IS NOT DESIGNED TO WITHSTAND THE STRESS OF WEIGHT BEARING, LOAD BEARING, OR EXCESSIVE PHYSICAL ACTIVITY. DEVICE LOOSENING OR BREAKAGE MAY OCCUR WHEN THE IMPLANT IS SUBJECTED TO EXCESSIVE LOADING DURING SOFT TISSUE HEALING OR DELAYED HEALING." "POTENTIAL IJS-E CONSTRUCT FAILURES SUCH AS STRESS FRACTURE OF THE BONES, LOOSENING OF THE CONSTRUCT, INSTABILITY, DELAYED SOFT TISSUE HEALING, SOFT TISSUE IRRITATION, OR INCOMPLETE HEALING MAY OCCUR AS A RESULT OF NON-COMPLIANCE TO POST-OPERATIVE REHABILITATION, EXCESSIVE ELBOW ACTIVITIES OR CONSTRUCT OVERLOADING." "THE PATIENT MUST BE CAUTIONED, PREFERABLY IN WRITING, ABOUT THE USE, LIMITATIONS AND POSSIBLE ADVERSE EFFECTS OF THIS DEVICE INCLUDING THE POSSIBILITY OF DEVICE OR TREATMENT FAILURE AS A RESULT OF LOOSE FIXATION AND/OR LOOSENING, STRESS, EXCESSIVE ACTIVITY, OR WEIGHT BEARING OR LOAD BEARING, AND THE POSSIBILITY OF NERVE OR SOFT TISSUE DAMAGE RELATED TO EITHER SURGICAL TRAUMA OR PRESENCE OF THE DEVICE." "THE PATIENT SHOULD BE INFORMED ABOUT THE IMPORTANCE OF FOLLOWING THE POST-OPERATIVE REHABILITATION PRESCRIBED IN ORDER TO FULLY UNDERSTAND THE POSSIBLE LIMITATIONS IN ACTIVITIES OF DAILY LIVING." THE SURGEON INDICATED THAT THE PATIENT HAS UNDERLYING CONDITIONS AND WAS NONCOMPLIANT, LIKELY LEADING TO FAILURE OF THE IMPLANT.

    Description of Event or Problem · 0

    AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) BROKE AT THE AXIS PIN EYELET TWO WEEKS FOLLOWING INITIAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828163 SKELETAL DYNAMICS INC. IJS-E BASE PLATE ASSEMBLY OZI SKELETAL DYNAMICS INC. 00841506104904

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Required Intervention