BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 15070153 · Received July 20, 2022

    Report

    Report Number
    3006742481-2022-00006
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Date of Event
    June 27, 2022
    Report Date
    July 18, 2022
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    OZI
    UDI-DI
    00841506104904
    PMA / PMN Number
    K153208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS PER THE IFU, "IF THE LOCKING SCREW OR THE AXIS PIN IS NOT FULLY TIGHTENED, THE CONSTRUCT MAY LOOSEN, SHIFT, AND/OR DISASSEMBLE." TESTING OF THIS PRODUCT HAS DETERMINED THAT, IF TIGHTENED PROPERLY, THE CONSTRUCT WILL NOT DISASSEMBLE UNDER NORMAL CONDITIONS. IT APPEARS THAT THIS SCREW WAS NOT TIGHTENED PROPERLY, RESULTING IN THE LOOSENED IMPLANT.

    Description of Event or Problem · 0

    DR. (B)(6) PERFORMED X-RAYS ABOUT A MONTH POST-IMPLANTATION AND FOUND THAT THE CONNECTING SCREW OF THE IJS-E IMPLANT HAD BACKED OUT AND MIGRATED DISTALLY UNDER THE OLECRANON. THIS SCREW IS A COMPONENT OF THE IMPLANT WHICH SECURES BOTH CONNECTING RODS TO EACH OTHER AND IS NOT INSTALLED INTO BONE. THE SURGEON HAS DECIDED TO LEAVE THE IMPLANT AS IS AND IMMOBILIZE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654107 SKELETAL DYNAMICS INTERNAL JOINT STABILIZER OZI SKELETAL DYNAMICS IJS-E Base Plate Assembly 00841506104904

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R