BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT

    MDR report key: 1910473 · Received November 24, 2010

    Report

    Report Number
    2530088-2010-00216
    Event Type
    Injury
    Date Received
    November 24, 2010
    Report Date
    October 26, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. INVESTIGATION IS ONGOING; 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

    PT IMPLANTED WITH PRODISC-C AT C5-C6 ON (B)(6) 2008. POSTOP PERIOD WAS UNEVENTFUL FOR 1 1/2 YEARS UNTIL PT BEGAN TO EXPERIENCE PAIN. SURGEON NOTED DEVELOPMENT OF CALCIFICATION. X-RAYS TAKEN ON AN UNK DATE. SURGEON PLANS TO REMOVE CALCIFICATION AND PRODISC-C IMPLANT ON (B)(6) 2010 AND REVISE PT TO ZERO-P.

    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 NA Male Required Intervention