BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2333258 · Received November 11, 2011

    Report

    Report Number
    1030489-2011-01459
    Event Type
    Injury
    Date Received
    November 11, 2011
    Report Date
    October 14, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: GLASSMAN ET AL. COMPLICATIONS WITH RECOMBINANT HUMAN BONE MORPHOGENIC PROTEIN-2 IN POSTEROLATERAL SPINE FUSION A CONSECUTIVE SERIES OF 1037 CASES. SPINE 2011; 36: 1849-1854. (B)(4). 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. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. MULTIPLE PRODUCTS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT MEDICAL RECORDS FOR A CONSECUTIVE SERIES OF 1037 PATIENTS WHO UNDERWENT POSTEROLATERAL SPINE FUSION USING RHBMP-2 WERE REVIEWED. THE 1037 PATIENTS IN THIS SERIES INCLUDED 637 FEMALES AND 400 MALES WITH A MEAN AGE OF 58.4 YEARS (RANGE: 18-90 YEARS). MEAN NUMBER OF SURGICAL LEVELS FUSED WAS 1.8 (RANGE: 1-5 LEVELS). ADDITIONAL GRAFT MATERIAL OR FILLERS INCLUDED LOCAL BONE IN 77.5% OF CASES, ICBG IN 35.4% OF CASES AND ALLOGRAFT BONE IN 33.6% OF CASES. LESS COMMONLY USED WERE DEMINERALIZED BONE MATRIX AND CERAMIC. POST-OPERATIVELY, 2 PATIENTS HAD ACUTE RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention