BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1705940 · Received May 28, 2010

    Report

    Report Number
    1030489-2010-00755
    Event Type
    Injury
    Date Received
    May 28, 2010
    Date of Event
    January 23, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). NON-UNION. LITERATURE ARTICLE CITATION: FALLUCCO ET AL. PRIMARY RECONSTRUCTION OF ALVEOLAR CLEFTS USING RECOMBINANT HUMAN BONE MORPHOGENIC PROTEIN-2; CLINICAL AND RADIOGRAPHIC OUTCOMES. THE JOURNAL OF CRANIOFACIAL SURGERY 2009; 1759-1764. 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 THE PT UNDERWENT A CLEFT REPAIR PROCEDURE USING RHBMP-2/ACS. IT WAS REPORTED THAT THE CLEFT SITE REPAIR FAILED TO MEET RADIOGRAPHIC CRITERIA OF DENTAL ARCH FUSION; HOWEVER, THE AESTHETIC RESULT WAS PLEASING, AND POSSIBILITY FOR SUBSEQUENT GRAFTING EXISTS. PER THE REPORTER, FAILURE IN THIS PARTICULAR CASE WAS ATTRIBUTED TO EXCESSIVE IRRIGATION OF THE IMPLANT SITE BEFORE FINAL CLOSURE, LEADING TO A "DILUTION EFFECT" OF PROTEIN FROM THE SPONGE. 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 Other