BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T INSERTER HANDLE

    MDR report key: 7553111 · Received May 29, 2018

    Report

    Report Number
    MW5077502
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    May 18, 2018
    Report Date
    May 25, 2018
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    OVD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    T INSERTER HANDLE BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393424 T INSERTER HANDLE INTERVERTEBRAL FUSION, LUMBAR OVD SPINAL ELEMENTS 72-06-1 REV A 23266005

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR