BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCURY MIS

    MDR report key: 4384286 · Received December 30, 2014

    Report

    Report Number
    3004893332-2014-00007
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Date of Event
    December 2, 2014
    Report Date
    December 4, 2014
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    NKB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    TIP OF K-WIRE BROKE OFF. SURGEON DECIDED TO LEAVE IT IN THE VERTEBRAL BODY AS IT WAS NOT CLOSE TO THE ANTERIOR ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858743 MERCURY MIS K-WIRE NKB SPINAL ELEMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other