BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 10299815 · Received July 20, 2020

    Report

    Report Number
    3006742481-2019-00003
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    August 14, 2019
    Report Date
    November 1, 2019
    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
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE PIN WAS SENT FROM THE SWIVEL PORTION OF THE CLAMP. THERE WAS ANECDOTAL EVIDENCE THAT THE PATIENT MIGHT HAVE BEEN IN AN ALTERCATION WITH A RESIDENT IN THE NURSING FACILITY. PER OUR IFU "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". THE EVIDENCE DOES NOT SUGGEST THAT THIS WAS A PRODUCT ISSUE BUT RATHER A USER ISSUE.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT ON AN MDR RECEIVED STATING AN ISSUE WITH THE IJS SYSTEM. THE REPORT STATED THAT THE PATIENT PRESENTED WITH A REPEAT LEFT ELBOW DISLOCATION WITH RADIOGRAPHS SUGGESTING THAT THE INTERNAL JOINT STABILIZER WAS EITHER FRACTURED OR DISASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763929 SKELETAL DYNAMICS NTERNAL HINGED ELBOW FIXATOR OZI SKELETAL DYNAMICS IJS-E Base Plate Assembly 00841506104904

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other