BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3443572 · Received November 1, 2013

    Report

    Report Number
    1030489-2013-04375
    Event Type
    Injury
    Date Received
    November 1, 2013
    Report Date
    April 11, 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)(6). (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 AN ALIF L5-S1 ON (B)(6) 2010 USING RHBMP-2/ACS. AN MRI STUDY CONDUCTED ON (B)(6) 2011 SHOWS A PERSISTENT FLUID COLLECTION THAT COMPROMISED THE FUSION HARDWARE, DISPLACING IT SO THAT IT OCCLUDED THE RIGHT-SIDED NEUROFORAMEN AS EVIDENCED ON A CT STUDY CONDUCTED ON THE SAME DATE. THIS FLUID COLLECTION DOES NOT RESOLVE, AND IS AGAIN EVIDENCED ON AN MRI STUDY DATED (B)(6) 2012. A LUMBAR EMG/NCV TAKEN ON (B)(6) 2012 FINDS THAT PLAINTIFF¿S PAIN GENERATOR IS THE RIGHT-SIDED NEUROFORAMEN FROM THE SAME LEVEL OF THE SPINE. BY COMPARISON, THERE IS NO IDENTIFIABLE FLUID COLLECTION ON THE PREOPERATIVE (B)(6) 2010 MRI STUDY. THE PATIENT HAS LOW BACK PAIN THAT RADIATES TO HIS LOWER EXTREMITIES. REPORTEDLY, REVISION SURGERY HAS BEEN RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563235 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110915AAJ

    Patients

    Seq Age Sex Outcome Treatment
    1