BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL ELEMENTS

    MDR report key: 6593615 · Received May 24, 2017

    Report

    Report Number
    MW5070036
    Event Type
    Malfunction
    Date Received
    May 24, 2017
    Date of Event
    May 16, 2017
    Report Date
    May 24, 2017
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE GEARSHIFT BROKE OFF INSIDE THE PT. BOTH PIECES OF THE GEARSHIFT WERE RECOVERED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368796 SPINAL ELEMENTS CURVED LENKE PROBE LXH SPINAL ELEMENTS 61023-000 130110

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR