BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 23631012 · Received November 24, 2025

    Report

    Report Number
    3006742481-2025-00010
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 21, 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 STATES THE FOLLOWING: "THE LOCKING SCREWS OF THE CONSTRUCT AND THE AXIS PIN MUST BE INSTALLED AND FULLY TIGHTENED TO ENSURE THAT THE CONSTRUCT WILL MAINTAIN THE POSITIONING AND ANGLES ESTABLISHED INTRAOPERATIVELY. IF THE LOCKING SCREWS OR THE AXIS PIN ARE NOT ATTACHED AND/OR FULLY TIGHTENED, THE CONSTRUCT MAY LOOSEN, SHIFT AND/OR BECOME DISASSEMBLED SUBCUTANEOUSLY." "THE IJS-E CONSTRUCT CONNECTING ROD SPLINES MUST BE FULLY SEATED PRIOR TO TIGHTENING. IMPROPER POSITIONING MAY RESULT IN LOOSENING OF THE CONSTRUCT." "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 IMPLANT BREAKAGE, LOOSENING, INSTABILITY, DELAYED SOFT TISSUE HEALING, SOFT TISSUE IRRITATION, OR INCOMPLETE HEALING MAY OCCUR AS A RESULT OF NON-COMPLIANCE TO POSTOPERATIVE REHABILITATION, EXCESSIVE ELBOW ACTIVITIES OR CONSTRUCT OVERLOADING." "THE PATIENT MUST BE CAUTIONED ABOUT THE USE, LIMITATIONS AND POSSIBLE ADVERSE EFFECTS OF THIS DEVICE INCLUDING THE POSSIBILITY OF DEVICE OR TREATMENT FAILURE AS A RESULT 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 THE PRESENCE OF THE DEVICE." THE PATIENT WAS UNDER THE IMPRESSION THAT THE IJS-E CONSTRUCT WAS MUCH STRONGER THAN IS INDICATED. THE PATIENT MAY HAVE STRESSED THE DEVICE BY ENGAGING IN EXCESSIVE PHYSICAL ACTIVITIES LIKE SWIMMING PRIOR TO WHEN SUFFICIENT HEALING COULD TAKE PLACE.

    Description of Event or Problem · 0

    A PATIENT EXPERIENCED REPEATED ISSUES WITH IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) CONSTRUCTS WITHIN 2-3 WEEKS OF INITIAL IMPLANTATION, INCLUDING BREAKAGE OF THE DISTAL CONNECTING ROD AND UNCOUPLING AT THE ARM JOINT (THE PROXIMAL LOCKING SCREW BACKED OUT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2389070 SKELETAL DYNAMICS INC. IJS-E BASE PLATE ASSEMBLY OZI SKELETAL DYNAMICS INC. 00841506104904

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Required Intervention