BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1705975 · Received May 28, 2010

    Report

    Report Number
    1030489-2010-00744
    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 PRESENTED FOR EMERGENCY TREATMENT FOR A DISPLACED RIGHT MANDIBULAR ANGLE FRACTURE. THE DEFECT WAS RECONSTRUCTED USING RHBMP-2/ACS. PT HAD SIGNIFICANTLY MORE SWELLING THAN IS USUALLY OBSERVED WITH AN AUTOGENOUS FREE BONE GRAFT. A PANORAMIC RADIOGRAPH AT 2 MONTHS POSTOPERATIVELY SHOWS INDUCTION OF BONE GROWTH WITHIN THE DEFECT. EIGHT MONTHS POST OP THE PT WAS STILL EXPERIENCING PAIN AT THE RECONSTRUCTION SITE. THERE WAS NO INFECTION AND THE MANDIBLE WAS RESTORED. PAIN DECREASED AND THE RECONSTRUCTION REMAINED COMPLETE FOR 22 MONTHS AFTER PLACING THE RHBMP-2 TISSUE ENGINEERED GRAFT.

    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 43 YR Required Intervention