BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JULIET INSTRUMENTATION

    MDR report key: 8939647 · Received August 28, 2019

    Report

    Report Number
    8939647
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 9, 2019
    Manufacturer
    SPINEART SA
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LARGE PIECE VENDOR INSTRUMENT BROKE OFF DURING CASE, NOTHING LEFT IN PATIENT. DID NOT DELAY OR COMPROMISE CASE. THE DEVICE BROKE IN THE WOUND. AN INTRAOPERATIVE X-RAY CONFIRMED THAT ALL OF THE PIECES WERE REMOVED PER THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735700 JULIET INSTRUMENTATION INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX SPINEART SA DYN-IT 00 01-N

    Patients

    Seq Age Sex Outcome Treatment
    1 18980 DA