BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1705942 · Received May 28, 2010

    Report

    Report Number
    1030489-2010-00754
    Event Type
    Injury
    Date Received
    May 28, 2010
    Date of Event
    July 18, 2006
    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). GRANULATION TISSUE FORMATION. LITERATURE ARTICLE CITATION: DICKINSON ET AL. REDUCED MORBIDITY AND IMPROVED HEALING WITH BONE MORPHOGENIC PROTEIN-2 IN OLDER PTS WITH ALVEOLAR CLEFT DEFECTS. PLASTIC AND RECONSTRUCTIVE SURGERY JOURNAL 2008; 209-217. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVAL. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A PROCEDURE TO CLOSE AN ALVEOLAR DEFECT USING INFUSE. IT WAS REPORTED POST-OP THAT THE PT EXPERIENCED PROLONGED WOUND HEALING AND GRANULATION TISSUE GROWTH. 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