BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1705970 · Received May 28, 2010

    Report

    Report Number
    1030489-2010-00751
    Event Type
    Injury
    Date Received
    May 28, 2010
    Date of Event
    January 1, 2008
    Report Date
    April 28, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). LITERATURE ARTICLE CITATION: CARTER ET AL. OFF-LABEL USE OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2) FOR RECONSTRUCTION OF MANDIBULAR BONE DEFECTS IN HUMANS. JOURNAL OF ORAL MAXILLOFACIAL SURGERY 2008; 66: 1417-1425. 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 THAT THE PT UNDERWENT A MANDIBLE RECONSTRUCTION SURGERY USING RHBMP-2/ACS. THE PT DEVELOPED MORE SOFT TISSUE SWELLING DURING THE IMMEDIATE POSTOPERATIVE PERIOD THAN IS USUALLY OBSERVED WITH AUTOGENOUS BONE GRAFTS. FIVE MONTHS POSTOPERATIVELY, THE PT HAD NOT DEVELOPED A BONY UNION. HER EXTERNAL FIXATION DEVICE WAS REMOVED AND SHE UNDERWENT AN ILIAC CREST BONE GRAFT RECONSTRUCTION WITH PLACEMENT OF A 2.4 MM RECONSTRUCTION PLATE TO STABILIZE HER CONTINUITY DEFECT. THE PT HAS CONTINUED TO HAVE A COMPLICATED POSTOPERATIVE COURSE REQUIRING THE REMOVAL OF THE RECONSTRUCTION PLATE AND MULTIPLE I&DS. THE BONE GRAFT HAS HEALED WITH REPAIR OF THE CONTINUITY DEFECT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention