BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT LARGE

    MDR report key: 1903467 · Received November 15, 2010

    Report

    Report Number
    2530088-2010-00179
    Event Type
    Injury
    Date Received
    November 15, 2010
    Report Date
    October 18, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFO HAS BEEN REQUESTED. INVESTIGATION IS ONGOING, NO CONCLUSION CAN BE DRAWN. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A PT IMPLANTED WITH PRODISC-C AT C5-C6 WAS RETURNED TO THE OPERATING ROOM FOR REVISION FIVE MONTHS POST IMPLANT. PT DEVELOPED ADJACENT DISC DISEASE AND SURGEON REVISED THE PT TO FUSION AT C4-C6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-C IMPLANT LARGE PRODISC-C IMPLANT LARGE MJO SYNTHES BRANDYWINE NA 6326889

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention