BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - PDL IMPLANT

    MDR report key: 2240947 · Received August 9, 2011

    Report

    Report Number
    2530088-2011-00506
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    PATIENT STATUS POST PRODISC-L IMPLANTATION L5-S1 AND NUVASIVE EMBRACE PRODUCT, REPORTED INTERMITTENT BACK PAIN: ON A SCALE OF 1 TO 10, PAIN WAS A 5. X-RAYS WERE TAKEN AND SHOWED TO POLYETHYLENE INLAY IS MIGRATING. SURGEON IS NOT SCHEDULING A REVISION OR REMOVAL AND IS MONITORING THE PATIENT. SURGEON BELIEVES THE NUVASIVE EMBRACE IMPLANTED WILL KEEP THE INLAY FROM MIGRATING. SURGEON NOTED: THERE ARE DOCUMENTED ABNORMALITIES ABOVE LEVEL L2-3 WHICH ARE CAUSING THE INTERMITTENT BACK PAIN. PATIENT CAN RESUME FULL ACTIVITY AND IS SCHEDULED FOR A ONE YEAR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK - PDL IMPLANT PRODISC-L IMPLANT MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR NUVASIVE EMBRACE: