BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC CERVICAL IMPLANT

    MDR report key: 2831942 · Received November 14, 2012

    Report

    Report Number
    2520274-2012-03121
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. INITIAL IMPLANT DATE UNKNOWN. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A PROCEDURE TO EXPLANT A PRODISC C (C5-C6) DUE TO OSTEOPHYTES GROWING OVER THE DISC, RESULTING IN LOSS OF MOBILITY. THE INITIAL IMPLANTATION DATE IS UNKNOWN. THE PRODISC C WAS REMOVED AND THE PATIENT WAS REVISED WITH A NON-SYNTHES PLATE. THIS IS REPORT #2 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC CERVICAL IMPLANT PRODISC CERVICAL IMPLANT MJO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention