BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 931828 · Received October 18, 2007

    Report

    Report Number
    MW5004160
    Event Type
    Other
    Date Received
    October 18, 2007
    Date of Event
    June 7, 2007
    Report Date
    October 18, 2007
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER HAVING PRODISC-L TOTAL DISC REPLACEMENT DEVELOPED SEROMAS IN THE LOWER ABDOMINAL CAVITY BETWEEN SKIN AND MUSCLE AND UNDER ABDOMINAL MUSCLE. IN 2007, RETURNED TO SURGERY TO REMOVE SEROMAS, 6 TO 8 SEROMAS WHERE FOUND AND REMOVED. A DRAIN WAS PLACED TO REMOVE EXCESS FLUID, HOWEVER, ONLY LASTED 3 TO 5 DAYS, NOW APPROX TWO MONTHS LATER, SEROMAS HAVE RETURNED. POSSIBLE PERITONEUM WHOLE OR LEAKAGE. BACK PAIN HAS ALSO RETURNED. PROCEDURE DOES NOT CALL FOR DRAIN TO BE PLACED AFTER ABDOMINAL INCISIONS ARE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PRODISC-L TOTAL DISC REPLACEMENT MJO SYNTHES (USA) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other