BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M6-C

    MDR report key: 7006570 · Received November 7, 2017

    Report

    Report Number
    MW5073163
    Event Type
    Injury
    Date Received
    November 7, 2017
    Date of Event
    August 2, 2007
    Report Date
    November 3, 2017
    Manufacturer
    SPINAL KINETICS
    Product Code
    MJO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    LITERATURE REPORTED CERVICAL TDR (TOTAL DISC REPLACEMENT) DEVICE PROCODE MJO "PRE-OPERATIVE IMAGING REVEALED EXTENSIVE PERIPROSTHETIC OSTEOLYSIS IN THE VERTEBRAL BODIES OF C4, C5, AND C6. THE PT SUBSEQUENTLY UNDERWENT REMOVAL OF THE ARTIFICIAL DISCS, CERVICAL CORPECTOMY WITH TITANIUM MESH CAGE (TMC), AND A COMBINED ANTERIOR AND POSTERIOR RECONSTRUCTION. PATHOLOGICAL EVALUATION OF VERTEBRAL BODY BONE ADJACENT TO THE IMPLANTS CONFIRMED METALLIC PARTICLES AND EXTENSIVE FOREIGN BODY GIANT CELL REACTION." RUZEVICK ET AL (2017) PERIPROSTHETIC OSTEOLYSIS AFTER 2 LEVEL CERVICAL DISC ARTHROPLASTY FEATURING ARTIFICIAL NUCLEUS, JACOBS JOURNAL OF SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785347 M6-C INTERVERTEBRAL DISC PROSTHESIS MJO SPINAL KINETICS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R| S