BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L SUPERIOR PLATE

    MDR report key: 1964020 · Received January 4, 2011

    Report

    Report Number
    2530088-2010-00238
    Event Type
    Injury
    Date Received
    January 4, 2011
    Report Date
    December 10, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO HAS NOT BEEN PROVIDED. ADDITIONAL INFO 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. MFR DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH PRODISC-L AT L5-S1. SURGEON INDICATED THE IMPLANT IS PLACED EVER SO SLIGHTLY TOO FAR TO THE LEFT AND PT IS EXPERIENCING CONTINUING PAIN. REPORTEDLY, THE PT BEGAN FEELING PAIN SOON AFTER THE IMPLANTATION. PT WILL BE REVISED. THIS REPORT IS #1 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-L SUPERIOR PLATE PRODISC-L SUPERIOR PLATE MJO SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention POLYETHLENE INLAY| INFERIOR PLATE