BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 19240048 · Received May 3, 2024

    Report

    Report Number
    3006742481-2024-00008
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 2, 2024
    Report Date
    May 2, 2024
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    OZI
    UDI-DI
    00841506104904
    PMA / PMN Number
    K153208
    Adverse Event
    Yes
    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 INCLUDE CONTRAINDICATIONS ADVISING AGAINST USE ON PATIENTS WITH "INSUFFICIENT QUANTITY OR QUALITY OF BONE (BONE LOSS GREATER THAN 30% OF THE TOTAL ARTICULATION OR INVOLVING AN ENTIRE COLUMN OF THE DISTAL HUMERUS, CORONOID BONE LOSS OF 50% OR MORE) AND/OR SOFT TISSUE". NO VISUALS WERE PROVIDED, HOWEVER THE SURGEON DID DESCRIBE THE PATIENT AS HAVING EXPERIENCED A TERRIBLE TRIAD INJURY WHICH ALSO INVOLVED IMPLANTATION OF A CORONOID PLATE. THIS PATIENT MAY NOT HAVE BEEN SUITABLE FOR IMPLANTATION OF THIS DEVICE GIVEN THE IJS-E SYSTEM'S CONTRAINDICATIONS FOR PATIENTS WITH SIGNIFICANT BONE LOSS AND/OR ADDITIONAL LOAD BEING APPLIED ONTO THE IJS-E CONSTRUCT AS A RESULT OF THEIR WEAKENED CORONOID BONE.

    Description of Event or Problem · 0

    AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) UNCOUPLED AT THE ARM JOINT (THE PROXIMAL LOCKING SCREW BACKED OUT) IN THE WEEKS FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99150 SKELETAL DYNAMICS INC. IJS-E BASE PLATE ASSEMBLY OZI SKELETAL DYNAMICS INC. 00841506104904

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention