BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT

    MDR report key: 1190052 · Received October 6, 2008

    Report

    Report Number
    2520274-2008-00079
    Event Type
    Injury
    Date Received
    October 6, 2008
    Report Date
    September 11, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO DETERMINE THE MANUFACTURE SITE OR THE MANUFACTURE DATE WITHOUT A LOT NUMBER. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    A PATIENT, IMPLANTED WITH PRODISC-C AT C4-C6, EXPERIENCING MUSCLE ATROPHY AND DECREASE IN USAGE OF ARM AND WAS RETURNED TO THE OR FOR REMOVAL OF THE IMPLANT AT C5-C6. SURGEON PLANS TO REVISE THE PATIENT TO FUSION AT C3-C6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-C IMPLANT PRODISC-C IMPLANTS MJO SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention