BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT

    MDR report key: 1905809 · Received November 19, 2010

    Report

    Report Number
    2530088-2010-00210
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    October 21, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH PRODISC-C COMPLAINED OF NECK PAIN. PRODISC-C WAS REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention