BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 4200500 · Received October 24, 2014

    Report

    Report Number
    1030489-2014-04127
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    December 2, 2005
    Report Date
    March 26, 2010
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P060018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE FOR IMPLANT OF ARTIFICIAL CERVICAL DISC AT C5-C6. AT 61 MONTHS POST-OP FOLLOW-UP, FLEXION AND EXTENSION CERVICAL X-RAYS SHOW THAT THE ARTIFICIAL DISC HAS GONE ON TO SPONTANEOUS FUSION. NO MOTION SEEN AT THE C5-6 LEVEL. NO TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678847 PRESTIGE CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA 721000

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Disability BONE SCREWS, LOCKING SCREW