BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JULIET INSTRUMENTATION

    MDR report key: 9847806 · Received March 18, 2020

    Report

    Report Number
    9847806
    Event Type
    Malfunction
    Date Received
    March 18, 2020
    Date of Event
    February 12, 2020
    Report Date
    February 13, 2020
    Manufacturer
    SPINEART USA INC
    Product Code
    MAX
    UDI-DI
    07640139349972
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IMPLANT HOLDER MICRO BROKE WHILE MD INSERTED AND TRIED TO PLACE INTERBODY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313794 JULIET INSTRUMENTATION INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX SPINEART USA INC JUL-IO 00 01-N 3-4939 07640139349972

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA