BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM

    MDR report key: 1983895 · Received February 4, 2011

    Report

    Report Number
    2246640-2011-00002
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    August 1, 2009
    Report Date
    January 7, 2011
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MBP
    PMA / PMN Number
    K051195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IN THIS MEDWATCH FORM 3500A WAS COMPLETED BY OSTEOTECH, INC. USING INFO PROVIDED IN THE FOLLOWING LITERATURE CITATION. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT BEING PROVIDED IN THE JOURNAL ARTICLE. LITERATURE ARTICLE CITATION: THAWRANI D, ET. AL. SUCCESSFUL TREATMENT OF UNICAMERAL BONE CYST BY SINGLE PERCUTANEOUS INJECTION OF ALPHA-BSM. J PEDIATR ORTHOP. JUL-AUG 2009; 29(5): 511-7. A REVIEW OF THE MANUFACTURING RECORDS FOR THE GRAFTON DBM PRODUCT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. NEITHER THE DEVICE NOR X-RAYS OF THE APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE, THE PT WAS A SUBJECT IN A STUDY TO EVALUATE CLINICAL AND RADIOGRAPHIC OUTCOMES OF UNICAMERAL BONE CYST TREATMENT USING A SINGLE INJECTION OF APATITIC CALCIUM PHOSPHATE (ALPHA-BSM). IT WAS REPORTED IN THE ARTICLE THAT THE PT HAD "PAST UNSUCCESSFUL TREATMENT" OF A UNICAMERAL BONE CYST USING" DEMINERALIZED BONE MATRIX (GRAFTON) INJECTION."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention METHYLPREDNISOLONE ACETATE