BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT LARGE

    MDR report key: 1873727 · Received October 14, 2010

    Report

    Report Number
    2530088-2010-00157
    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
    DE, 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 PRODISC-C IMPLANTATION RETURNED TO SURGEON FOR POST OP VISIT. THE PT WAS ASYMPTOMATIC AND AN X-RAY SHOWED THE SUPERIOR END PLATE SHIFTED ANTERIORLY. THE PRODISC-C WAS IMPLANTED ABOVE AN ACDF FUSION PREVIOUSLY IMPLANTED. SURGEON REMOVED THE HARDWARE AND REVISED TO PLATE AND SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-C IMPLANT LARGE PRODISC-C IMPLANT MJO SYNTHES BRANDYWINE NA 6237003

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention