BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1171227 · Received September 17, 2008

    Report

    Report Number
    1030489-2008-00512
    Event Type
    Injury
    Date Received
    September 17, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 FILLING THIS MDR FOR NOTIFICATION PURPOSES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY DR. IN A PUBLICATION ENTITLED "PROSPECTIVE NONRANDOMIZED COMPARISON OF AN ALLOGRAFT WITH BONE MORPHOGENIC PROTEIN VERSUS AN ILIAC-CREST AUTOGRAFT IN ANTERIOR CERVICAL DISCECTOMY AND FUSION" (THE SPINE JOURNAL 8 (2008) 426-435) THAT 3 PTS DEVELOPED NECK SWELLING CAUSING DYSPHAGIA AFTER ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURES WHERE RHBMP WAS IMPLANTED. EACH OF THE THREE PTS WAS READMITTED TO THE ICU FOR OBSERVATION AND INTRAVENOUS STEROID ADMINISTRATION DUE TO THE DYSPHAGIA. ALL THREE CASES RESOLVED, AND THERE WERE NO REQUIRED SURGERIES.

    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 UNK