BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT SMALL KIT

    MDR report key: 1705955 · Received May 28, 2010

    Report

    Report Number
    1030489-2010-00736
    Event Type
    Injury
    Date Received
    May 28, 2010
    Date of Event
    September 10, 2009
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). LITERATURE ARTICLE CITATION: ALONSO ET AL. MAXILLARY ALVEOLAR RECONSTRUCTION ON CLEFT LIP AND PALATE PATIENTS USING RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2. COMPARISON WITH AUTOGENOUS BONE GRAFTING. TISSUE ENGINEERING. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. NEITHER THE DEVICE NOR FILMS OF 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ALVEOLAR BONE GRAFTING PROCEDURE USING RHBMP-2/ACS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANT SWELLING IN THE EARLY POST OP PERIOD. THE SWELLING RESOLVED UNEVENTFULLY. PER THE REPORTER, THIS WAS NOT ATTRIBUTED TO BMP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK