BEUDAMED
    FDA Adverse Event Summary report: N

    MECURY

    MDR report key: 4254919 · Received November 11, 2014

    Report

    Report Number
    3004893332-2014-00002
    Date Received
    November 11, 2014
    Date of Event
    October 22, 2014
    Report Date
    November 11, 2014
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    NKB
    PMA / PMN Number
    K083230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DURING A FOLLOW UP APPOINTMENT, X-RAY SHOWED A FRACTURED POLYAXIAL SCREW IN A PATIENT'S SACRUM. AT THE MOMENT THE DOCTOR HAS DECIDED TO NOT REMOVE IT AND MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726448 MECURY POLYAXIAL SCREW NKB SPINAL ELEMENTS, INC. 620X5-0XX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization