BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT

    MDR report key: 1952114 · Received January 4, 2011

    Report

    Report Number
    2530088-2011-00001
    Event Type
    Injury
    Date Received
    January 4, 2011
    Report Date
    December 10, 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

    THIS INFORMATION HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A PRODISC-C IMPLANT PLACED AT C4-C5 ON AN UNK DATE WAS REMOVED DUE TO PT'S CONTINUED NECK PAIN.

    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 42 YR Required Intervention