BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 2497391 · Received March 20, 2012

    Report

    Report Number
    1030489-2012-00328
    Event Type
    Injury
    Date Received
    March 20, 2012
    Date of Event
    November 1, 2010
    Report Date
    February 27, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS IMPLANTED DURING THE IDE STUDY. THE APPROVED DEVICE PRODUCT CODE IS MJO, PMA# P060018. THE DEVICE OR APPLICABLE IMAGING STUDIES HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN ARTIFICIAL CERVICAL DISC AT C5-6. APPROXIMATELY 83 MONTHS POST-OP, THE PATIENT WAS NOTED TO HAVE AUTO-FUSED AT THE LEVEL OF THE ARTIFICIAL DISC. AT 84 MONTHS POST-OP, THE PATIENT WAS ASYMPTOMATIC WITH NO NECK PAIN OR DEFICITS ASSOCIATED WITH THE CERVICAL SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE CERVICAL DISC SYSTEM MJO WARSAW ORTHOPEDICS NA 721060

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Other