BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2827952 · Received November 12, 2012

    Report

    Report Number
    1030489-2012-02074
    Event Type
    Injury
    Date Received
    November 12, 2012
    Report Date
    October 13, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: DODWELL ET AL. OFF-LABEL USE OF BONE MORPHOGENETIC PROTEINS IN PEDIATRIC SPINAL ARTHRODESIS. JAMA; OCTOBER 10, 2012; VOL 308, NO. 14: 1429-1432. A2: PEDIATRIC. (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. PRODUCTS FROM MULTIPLE MANUFACTURERS 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 THE (B)(6), HEALTHCARE COST AND UTILIZATION PROJECT, WAS REVIEWED TO DETERMINE THE PREVALENCE OF BMP USE, ASSOCIATED COMPLICATIONS, COSTS, AND POTENTIAL PREDICTORS OF USE IN PEDIATRIC SPINAL ARTHRODESIS IN THE UNITED STATES. THE AUTHORS INCLUDED CHILDREN AGED 18 YEARS OR YOUNGER WHO HAD UNDERGONE PRIMARY OR REVISION SPINE ARTHRODESIS IN 2009. COMPLICATIONS ASSESSED INCLUDED MEDICAL, NEUROLOGICAL, WOUND HEALING, INFECTIOUS, AND THOSE RELATED TO BREATHING AND DYSPHAGIA. NATIONALLY, BMP WAS ESTIMATED TO BE USED IN 9.2% (95% CI, 7.3%-11.0%; UNWEIGHTED N=771) OF CASES. THE ESTIMATED PREVALENCE OF IN-HOSPITAL COMPLICATIONS IN THOSE WHO RECEIVED BMP WAS 24 PATIENTS AND IN THOSE WHO DID NOT RECEIVE BMP WAS 271.

    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 Required Intervention