BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3895386 · Received June 25, 2014

    Report

    Report Number
    1030489-2014-02916
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    January 16, 2018
    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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 IN WHICH RHBMP-2/ACS WAS USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A POSTEROLATERAL AND TRANSFORAMINAL LUMBAR INTERBODY FUSION FROM L5 TO S1 USING RHBMP-2/ACS ON (B)(6) 2011. THE RHBMP-2 WAS PLACED IN THE DISC SPACE AND LATERAL GUTTERS. SOMETIME POSTOP, THE PATIENT REPORTEDLY EXPERIENCED PAIN WHICH RADIATES TO HIS HIPS, GROIN, AND LOWER EXTREMITIES. A LUMBAR MRI PERFORMED ON (B)(6) 2013, REVEALED A FLUID COLLECTION OVER MULTIPLE LEVELS OF THE PATIENT¿S LUMBAR SPINE. A LUMBAR MRI PERFORMED ON (B)(6) 2013, REVEALED BONY OVERGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369960 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111112AAZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other