BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 10299810 · Received July 20, 2020

    Report

    Report Number
    3006742481-2020-00001
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    July 9, 2019
    Report Date
    January 3, 2020
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    OZI
    UDI-DI
    00841506104904
    PMA / PMN Number
    K153208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED UNIT REVEALED THAT THE PROXIMAL CONNECTING ROD WAS THE ONLY COMPONENT BROKEN. THE VISUAL INSPECTION ALSO SHOWED DAMAGES IN THE AXIS PIN THREAD, AS WELL AS IN THE PROXIMAL CONNECTING ROD. THESE DAMAGES CAN BE CAUSED BY FACTORS LIKE DAMAGED THREADS AND/OR OVER-TORQUING. SINCE DAMAGE THREADS ARE PART OF THE INSPECTION PERFORMED IN HOUSE, IT IS CONSIDERED UNLIKELY THAT THE DEVICE WOULD REACH THE FIELD WITH THIS TYPE OF DEFECT. AFTER REVIEWING THE NONCONFORMANCE AND COMPLAINT DATA BASE, NO NONCONFORMITY OR COMPLAINT EVENT RELATED WITH THESE TWO FACTORS/CAUSES WERE FOUND. EVIDENCES FOUND DURING THE INVESTIGATION POINTS TO A POSSIBLE OVER-TORQUING DURING ASSEMBLY.

    Description of Event or Problem · 1

    BROKEN IJS PROXIMAL CONNECTING ROD. PARTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763925 SKELETAL DYNAMICS INTERNAL JOINT STABALIZER OZI SKELETAL DYNAMICS IJS-E Base Plate Assembly 00841506104904

    Patients

    Seq Age Sex Outcome Treatment
    1 Other