BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT MEDIUM

    MDR report key: 1873714 · Received October 14, 2010

    Report

    Report Number
    2530088-2010-00156
    Event Type
    Injury
    Date Received
    October 14, 2010
    Report Date
    September 24, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PT STATUS POST 2 LEVEL PDC IMPLANTATION TWO LEVELS C5-6 AND C6-7 RETURNED TO SURGEON COMPLAINING OF PAIN IN THE NECK AND DOWN HER SHOULDER. X-RAYS SHOWED THE PT HAD DEVELOPED FACET ARTHROPATHY. SURGEON NOTED PT HAD BEEN PAIN FREE AFTER THE IMPLANTATION. SURGEON REMOVED THE HARDWARE AND REVISED TO FUSION WITH SPACERS AND PLATE. THIS IS TWO OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-C IMPLANT MEDIUM PRODISC-C MJO SYNTHES BRANDYWINE NA 6097613

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention PRODISC-C