BEUDAMED
    FDA Adverse Event Other Summary report: N

    GRAFTON PUTTY 10CC

    MDR report key: 935969 · Received October 31, 2007

    Report

    Report Number
    2249062-2007-00014
    Event Type
    Other
    Date Received
    October 31, 2007
    Date of Event
    October 20, 2007
    Report Date
    October 31, 2007
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MBP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN 2007, A PT HAD "L4-S1 FUSION WITH RODS & BONE ALLOGRAFT AND L4-L5 LAMINECTOMY FOR DECOMPRESSION." ON THE NEXT DAY, THE PT PRESENTED WITH A FEVER. THERE WAS NO REDNESS OR SWELLING AT THE INCISION SITE. AS OF THREE DAYS LATER, THE PT WAS NO LONGER HAD A FEVER. PENDING FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON PUTTY 10CC BONE VOID FILLER MBP OSTEOTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R SEE MW REPORT 3001236616-2007-0034| "DEPUY MONARCH IMPLANTS"