BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS, INC.

    MDR report key: 19092955 · Received April 11, 2024

    Report

    Report Number
    3006742481-2024-00005
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 9, 2024
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    OZI
    UDI-DI
    00841506104904
    PMA / PMN Number
    K153208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE IJS-E SYSTEM INCLUDES THE FOLLOWING WARNING: "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 PATIENT DID NOT FOLLOW THE POST-OPERATIVE REHABILITATION PRESCRIBED BY THE SURGEON, STRESSING THE IMPLANT BY WORKING IN THE FIELDS OF THEIR FARM ONLY THREE WEEKS AFTER INITIAL IMPLANTATION.

    Description of Event or Problem · 0

    AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) BROKE AT THE BASE OF THE BOOM ARM FOUR WEEKS AFTER INITIAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333348 SKELETAL DYNAMICS, INC. IJS-E BASE PLATE ASSEMBLY OZI SKELETAL DYNAMICS INC. AN2304007 00841506104904

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention