BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4163509 · Received October 10, 2014

    Report

    Report Number
    1030489-2014-04003
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: GUPPY ET AL. DOES BONE MORPHOGENIC PROTEIN (BMP) CHANGE THE OPERATIVE NONUNION RATES IN SPINE FUSIONS? SPINE (2014) DOI: 10.1097/BRS.0000000000000534. A2: MEAN AGE 61.8 YEARS (RANGE 21-96). A3: 3122 FEMALES, 2334 MALES. (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 THAT THE AUTHORS IDENTIFIED 9425 SPINAL FUSION CASES BETWEEN 2009 AND 2011 FROM A SPINE REGISTRY IN A LARGE INTEGRATED HEALTHCARE ORGANIZATION. IN THE COHORT, THERE WERE 5,456 BMP CASES AND 3 ,969 NON-BMP CASES. ONE NON-UNION OCCURRED IN CERVICAL-THORACIC FUSION APPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640564 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 00060 YR Other