BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1705959 · Received May 28, 2010

    Report

    Report Number
    1030489-2010-00729
    Event Type
    Injury
    Date Received
    May 28, 2010
    Report Date
    April 28, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NPZ
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). LITERATURE ARTICLE CITATION: CHIN ET AL. REPAIR OF ALVEOLAR CLEFTS WITH RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN (RHBMP-2) IN PTS WITH CLEFTS. THE JOURNAL OF CRANIOFACIAL SURGERY 2005; 16: 778-789. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADD'L DEVICE INFO. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT UNDERWENT A PROCEDURE TO REPAIR A CONGENITAL FACIAL CLEFT USING INFUSE. THE PT HAD A DEFICIENCY IN BONE AT 49 DAYS POST OP, AND DID NOT HAVE A STABLE UNION. ANOTHER SURGERY, ADDING MORE BMP-2 TO THE SITE RESULTED IN UNION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT INFUSE BONE GRAFT NPZ MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention