BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1583498 · Received January 20, 2010

    Report

    Report Number
    1030489-2010-00071
    Event Type
    Injury
    Date Received
    January 20, 2010
    Report Date
    December 22, 2009
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NPZ
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS FROM MULTIPLE MFRS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNK IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. 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 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 BY THE HEALTH CARE PROFESSIONAL (HCP) THAT THE PT UNDERWENT A GRAFTING PROCEDURE IN THE #3 TOOTH AREA USING TITANIUM MESH AND RHBMP-2/ACS. SIX MONTHS POST-OP, THE MESH HAD BECOME EXPOSED, AND A SURGICAL PROCEDURE WAS CONDUCTED TO REPAIR THE SITE. DURING THE SURGERY, THE HCP NOTED THAT ALTHOUGH SOME BONE FORMED, PRIMARILY THE GRAFTED AREA SHOWED A "GREEN BLOB" OF "GRANULATION MATERIAL". THE MATERIAL WAS DEBRIDED AND SENT TO PATHOLOGY FOR TESTING. RESULTS ARE NOT AVAILABLE AT THIS TIME. THE HCP IS ANTICIPATING THAT THE PT WILL RETURN TO THE OR AT A LATER TIME FOR MORE DEFINITIVE SURGERY.

    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 Required Intervention