BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1133030 · Received August 20, 2008

    Report

    Report Number
    1030489-2008-00445
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    May 27, 2008
    Report Date
    July 21, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT, DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION, WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL CORPECTOMY AND FUSION AT C4-6 USING A STRUT GRAFT AND RHBMP-2/ACS. POST-OPERATIVELY, THE PATIENT IS REPORTED TO HAVE DEVELOPED MASSIVE NECK SWELLING, VERY THICK, VISCOUS TRACHEAL AND BRONCHIAL SECRETIONS, MAJOR AIRWAY PROBLEMS, AND REQUIRED TRACHEOSTOMY.

    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 M110602AAL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention