BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1705961 · Received May 28, 2010

    Report

    Report Number
    1030489-2010-00712
    Event Type
    Injury
    Date Received
    May 28, 2010
    Date of Event
    May 1, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). LITERATURE ARTICLE CITATION: CHAO ET AL. IN SITY OSTEOGENESIS OF HEMIMANDIBLE WITH RHBMP-2 IN A (B) (6): OSTEOINDUCTION VIA STEM CELL CONCENTRATION. J OF CRANIOFACIAL SURGERY 2006; 17: 405-412. 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 RECONSTRUCTIVE SURGERY FOR A RAPIDLY GROWING RIGHT MANDIBULAR MASS USING RHBMP-2/ACS. THE INITIAL POSTOPERATIVE 3D CT SCAN AT 6 WEEKS SHOWED BONE FILLING THE DEFECT FROM EDGE TO EDGE, WITH ONLY A SMALL AREA OF LUCENCY NEAR THE MESIAL MARGIN. THE HARDWARE WAS REMOVED AT 8 WEEKS. MUCOSAL DEHISCENCE WAS FOUND CORRESPONDING TO THE ZONE OF LUCENCY.

    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 9 YR Required Intervention