BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON PLUS DBM PASTE

    MDR report key: 1970360 · Received January 14, 2011

    Report

    Report Number
    2246640-2010-00007
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    July 13, 2010
    Report Date
    December 15, 2010
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MBP
    PMA / PMN Number
    K043048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL DONOR AND MFG RECORDS RELATIVE TO THE SUBJECT GRAFT WERE REVIEWED AND INDICATED THAT THE GRAFT COMPLIED WITH OSTEOTECH'S RELEASE CRITERIA AND MET ALL PRODUCT SPECIFICATIONS. THERE WERE NO DEFICIENCIES IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH THE PROCESSING OF THIS GRAFT. TO DATE, NO ADDITIONAL REPORTS OF THIS NATURE HAVE BEEN RECEIVED RELATIVE TO ANY OTHER PRODUCTS PRODUCED FROM THIS DONOR TISSUE. OSTEOTECH'S MEDICAL DIRECTOR HAS MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO CONTACT THE SURGEON FOR FURTHER INFO, HOWEVER NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. OSTEOTECH'S MEDICAL DIRECTOR HAS REVIEWED THE CASE AND CONCLUDED THAT THERE IS NO EVIDENCE TO INDICATE ANY PROBLEM WITH THE PRODUCT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT UNDERWENT A RESECTION OF AN ILIAC UNICAMERAL BONE CYST UTILIZING FOUR-STEP CURETTAGE, HIGH SPEED BURRING, CAUTERIZATION AND PHENOLIZATION OF THE INTERIOR WALL OF THE CYST. THE DEFECT WAS GRAFTED USING AUTOGENOUS BONE MARROW GRAFT COMBINED WITH THE "ALLOGRAFT ALLOMATRIX STRIP (ASSUMED TO BE GRAFTON MATRIX STRIP) AND GRAFTON PASTE RECONSTRUCTION." THE VOLUME OF EACH PRODUCT THAT WAS IMPLANTED IS UNK. ON F/U VISITS (ELAPSED TIME UNK) THE PT WAS HAVING PAIN, AND POST-OPERATIVE IMAGING (ELAPSED TIME UNK) "DID NOT SHOW THAT THE BONE GRAFT WAS GETTING INCORPORATED INTO THE PT BONE." THE PT WAS DIAGNOSED WITH POSSIBLE RECURRENCE OF THE CYST AND UNDERWENT A SECOND SURGERY ON (B)(6) 2010, WITH FROZEN SECTION AND CULTURE OF THE CYST. PATHOLOGY REPORT SHOWED "BONE GRAFT MATERIAL AND LOOSE FIBROUS STROMA WITH RARE AGGREGATES OF LYMPHOCYTES." THERE WAS NO EVIDENCE OF INFECTION ON GRAM STAIN AND CULTURE AND NO RECURRENCE OF THE CYST. SURGEON CONCLUDED THAT THERE MAY HAVE BEEN "A PROBLEM WITH THE BONE GRAFT INCORPORATION FROM THE FIRST OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON PLUS DBM PASTE DEMINERALIZED BONE MATRIX ALLOGRAFT MBP OSTEOTECH, INC. 10CC OTSCT0834014092

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R