BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 23733230 · Received December 5, 2025

    Report

    Report Number
    3006742481-2025-00012
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 4, 2025
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    OZI
    UDI-DI
    00841506104904
    PMA / PMN Number
    K153208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE IJS-E SYSTEM INCLUDES THE FOLLOWING POTENTIALLY RELEVANT WARNINGS AND PRECAUTIONS: "THE IJS-E CONSTRUCT IS INTENDED TO BE EXPLANTED WHEN TISSUE HEALING HAS PROVEN SUFFICIENT FOR JOINT STABILITY. FAILURE TO REMOVE THE IMPLANT AFTER TISSUE HEALING INCREASES LIKELIHOOD OF THE DEVICE TO BEND, BREAK, DISASSEMBLE, CAUSE LOCALIZED TISSUE REACTIONS, PAIN, OR DISCOMFORT." "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 FAILURES 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 BENEFITS FROM IMPLANT SURGERY MAY NOT MEET THE PATIENT'S EXPECTATIONS OR MAY DETERIORATE OVER TIME, REQUIRING REVISION SURGERY TO REPLACE THE IMPLANT OR TO CARRY OUT ALTERNATIVE PROCEDURES." "THE IJS-E SYSTEM HAS NOT BEEN EVALUATED IN PATIENTS WITH INSTABILITY SECONDARY TO SURGICAL RELEASE OF SOFT TISSUE." ALTHOUGH IT CANNOT BE CONFIRMED AT THIS TIME WITH THE LIMITED INFORMATION AVAILABLE, THE IJS-E CONSTRUCT MAY HAVE BEEN IMPROPERLY STRESSED, RESULTING IN FAILURE.

    Description of Event or Problem · 0

    THE AXIS PIN BACKED OUT OF A PATIENT'S IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) CONSTRUCT AFTER 15 WEEKS, REQUIRING ADDITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168366 SKELETAL DYNAMICS INC. IJS-E BASE PLATE ASSEMBLY OZI SKELETAL DYNAMICS INC. 00841506104904

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention