BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCURY CLASSIC

    MDR report key: 4349443 · Received December 11, 2014

    Report

    Report Number
    3004893332-2014-00006
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 10, 2014
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    NKB
    PMA / PMN Number
    K091587
    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

    AND 2 SCREWS WERE DISCOVERED BROKEN DURING A PRE-EXPLANATION X-RAY VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803652 MERCURY CLASSIC PEDICLE SCREW SPINAL SYSTEM NKB SPINAL ELEMENTS, INC. 120645

    Patients

    Seq Age Sex Outcome Treatment
    1 Other