BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCURY

    MDR report key: 5064095 · Received September 9, 2015

    Report

    Report Number
    3004893332-2015-00010
    Event Type
    Injury
    Date Received
    September 9, 2015
    Date of Event
    September 18, 2015
    Report Date
    November 2, 2015
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    NKB
    PMA / PMN Number
    K071914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POST-OPERATIVE X-RAY REVEALED CAGE BREAKAGE/MIGRATION. REVISION SURGERY HAS BEEN SCHEDULED.

    Description of Event or Problem · 1

    POST-OPERATIVE X-RAY REVEALED CAGE BREAKAGE/MIGRATION. REVISION SURGERY HAS BEEN SCHEDULED. REVISION SURGERY PERFORMED (B)(6) 2015 REVEALED SCREW DISASSOCIATION CAUSING THE CAGE MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596916 MERCURY PEDICLE SCREW SYSTEM NKB SPINAL ELEMENTS, INC. 140385

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention