BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE

    MDR report key: 8042082 · Received November 6, 2018

    Report

    Report Number
    2135156-2018-00010
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 3, 2018
    Report Date
    November 6, 2018
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    MAX
    UDI-DI
    M7405410014
    PMA / PMN Number
    K162879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE IMPLANT WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME DESIGN APPROXIMATELY 11 WEEKS POST-OP. REPORTEDLY X-RAY IMAGING INDICATED THAT THE IMPLANT COLLAPSED, AND THE BOLT WAS BROKEN. NO INFORMATION ABOUT THE PATIENT'S CONDITION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883022 ELITE INTERVERTEBRAL BODY FUSION DEVICE MAX SPINEOLOGY INC. S80440 M7405410014

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR