BEUDAMED
    FDA Adverse Event Other Summary report: N

    GRAFTON PLUS DBM PASTE

    MDR report key: 1943744 · Received December 17, 2010

    Report

    Report Number
    2246640-2010-00003
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 17, 2010
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MBP
    PMA / PMN Number
    K043048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, A DISTRIBUTOR OUTSIDE OF THE U.S. REPORTED THAT A PT, WHO HAD UNDERGONE A "SCOLIOSIS-RELATED DEFORMITY CORRECTION" IN (B)(6) 2010 USING GRAFTON PASTE, HAD EXPERIENCED A POST-OPERATIVE INFLAMMATORY REACTION WITH "LOCAL OOZING FROM THE WOUND". NO ADD'L DETAILS ABOUT THE CASE WERE KNOWN OR PROVIDED BY THE INITIAL REPORTER. NO LOT INFO WAS PROVIDED. A LIST OF DETAILED F/U QUESTIONS HAS BEEN SUBMITTED TO THE INITIAL REPORTER, AND WE HAVE MADE MULTIPLE UNSUCCESSFUL F/U ATTEMPTS WITH THE DISTRIBUTOR TO OBTAIN THE INFO (ON (B)(6) 2010). IT IS UNK AT THIS TIME IF THE EVENT NECESSITATED ANY SUBSEQUENT MEDICAL OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON PLUS DBM PASTE BONE VOID FILLER, OSTEOINDUCTIVE MBP OSTEOTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other