BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS, INC.

    MDR report key: 19487746 · Received June 7, 2024

    Report

    Report Number
    3006742481-2024-00010
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 9, 2024
    Report Date
    June 7, 2024
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    OZI
    UDI-DI
    00841506109138
    PMA / PMN Number
    K231447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE IJS-E SYSTEM STATES THE FOLLOWING: "IMPROPER PLACEMENT, POSITIONING, ALIGNMENT OR FIXATION OF THE IJS-E CONSTRUCT MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE COMPONENTS, CONSTRUCT FAILURE, POSTOPERATIVE COMPLICATIONS OR INEFFECTIVE TREATMENT." "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." ALTHOUGH THIS CANNOT BE CONFIRMED AT THIS TIME AS THIS IS THE FIRST KNOWN FAILURE OF ITS KIND AND THE DEVICE WAS NOT AVAILABLE FOR RETURN, THE PATIENT'S WEIGHT MAY HAVE STRESSED THE CONSTRUCT TO THE POINT OF FAILURE AFTER EIGHT WEEKS OF USE.

    Description of Event or Problem · 0

    AN IMPLANTED DOUBLE IJS-E (INTERNAL JOINT STABILIZER - ELBOW) BROKE AT THE BASE OF THE MEDIAL BOOM ARM EIGHT WEEKS FOLLOWING INTIAL IMPLANTATION, REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265858 SKELETAL DYNAMICS, INC. DOUBLE IJS-E, ASSEMBLY OZI SKELETAL DYNAMICS INC. 00841506109138

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention