BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL JOINT STABILIZER - ELBOW BASE PLATE ASSEMBLY

    MDR report key: 14091181 · Received April 12, 2022

    Report

    Report Number
    3006742481-2022-00003
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 8, 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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE PROBLEMS WERE IDENTIFIED. REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO FURTHER ISSUES HAVE BEEN IDENTIFIED. THE IFU STATES "IF THE LOCKING SCREWS OR THE AXIS PIN IS NOT FULLY TIGHTENED, THE CONSTRUCT MAY LOOSEN, SHIFT, AND/OR DISASSEMBLE." AS PER WITNESS, IT WAS STATED THAT THE SURGEON DID NOT PROPERLY TIGHTEN THE CONSTRUCT WHICH CONTRIBUTED TO MALFUNCTION POST-IMPLANTATION.

    Description of Event or Problem · 0

    SURGEON IDENTIFIED LOOSE IJS CONSTRUCT 10 DAYS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297113 INTERNAL JOINT STABILIZER - ELBOW BASE PLATE ASSEMBLY IJS- ELBOW ASSEMBLY OZI SKELETAL DYNAMICS IJS-E Base Plate Assembly 00841506104904

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Required Intervention