BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2696186 · Received August 14, 2012

    Report

    Report Number
    1030489-2012-01372
    Event Type
    Injury
    Date Received
    August 14, 2012
    Report Date
    July 17, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NPZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7510200, PRODUCT CODE NEK WAS CLEARED IN THE UNITED STATES. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION SURGERY TO TREAT ADJACENT LEVEL DISEASE. THE PREVIOUS FUSION WAS EXTENDED TO THE SACRUM/ILIAC (L5-S1) USING INTERBODY DEVICES, POSTERIOR FIXATION, AND RHBMP-2/ACS. THE PATIENT DID NOT FUSE AT L5-S1, AND REQUIRED A REVISION SURGERY 133 DAYS POST-OP, TO RE-ATTEMPT TO FUSION OF L5-S1.

    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 NPZ MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PEEK INTERBODY CAGES, POSTERIOR INSTRUMENTATION