BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 22980564 · Received September 5, 2025

    Report

    Report Number
    3006742481-2025-00008
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 6, 2025
    Report Date
    September 5, 2025
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    OZI
    UDI-DI
    00841506104904
    PMA / PMN Number
    K172688
    Product Problem
    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 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," REVIEW OF THE IMAGES FROM THE INITIAL CASE FOUND THAT THE SURGEON LIKELY DID NOT FULLY SEAT THE CONNECTING ROD SPLINES, PREVENTING THE LOCKING SCREW FROM BEING ABLE TO ADEQUATELY TIGHTEN THE ARM JOINT OF THE CONSTRUCT.

    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) ONE WEEK FOLLOWING INITIAL IMPLANTATION, REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263804 SKELETAL DYNAMICS INC. IJS-E BASE PLATE ASSEMBLY OZI SKELETAL DYNAMICS INC. 00841506104904

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention