BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROMEO 2 INSTRUMENTATION

    MDR report key: 12646916 · Received October 18, 2021

    Report

    Report Number
    12646916
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 15, 2021
    Report Date
    September 21, 2021
    Manufacturer
    SPINEART SA
    Product Code
    MNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ROD REDUCER FROM SPINE ART SYSTEM FRACTURED IN USE BY SURGEON. A SLIVER OF PLASTIC 1 MM X 2 MM WAS UNACCOUNTED FOR FROM THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543835 ROMEO 2 INSTRUMENTATION ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION MNH SPINEART SA ELL-IN 10 34-N

    Patients

    Seq Age Sex Outcome Treatment
    1 13870 DA