BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISCERA RETAINER RADIOPAQUE CENTER SPINE

    MDR report key: 20311780 · Received September 25, 2024

    Report

    Report Number
    MW5160108
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    September 19, 2024
    Report Date
    September 19, 2024
    Manufacturer
    RAINBOW MEDICAL DEVICES LLC
    Product Code
    GCZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGEON NOTED THAT A PIECE OF WHAT APPEARED TO BE SMALL PLASTIC WAS IN THE PATIENT. UPON REMOVAL AND INSPECTION, IT WAS NOTED THAT A SMALL PIECE OF THE VISCERA RETAINER HAD BROKEN OFF FROM THE O RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830876 VISCERA RETAINER RADIOPAQUE CENTER SPINE RETAINER, SURGICAL GCZ RAINBOW MEDICAL DEVICES LLC 2309260

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other