BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K2M GEARSHIFT

    MDR report key: 7556523 · Received May 30, 2018

    Report

    Report Number
    MW5077542
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    May 25, 2018
    Report Date
    May 29, 2018
    Manufacturer
    K2M, INC.
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS HAMMERING THE K2M GEARSHIFT INTO PT'S VERTEBRAL BODY OF THE SPINE. THE TIP OF THE GEAR SHIFT BROKE OFF INTO THE VERTEBRAL BODY. IT WAS DECIDED TO LEAVE THIS IN PLACE SINCE TO ATTEMPT TO RETRIEVE IT WOULD CAUSE MORE HARM THAN LEAVING IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394153 K2M GEARSHIFT GEARSHIFT MAX K2M, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other