BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3920216 · Received July 8, 2014

    Report

    Report Number
    1030489-2014-03133
    Event Type
    Injury
    Date Received
    July 8, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2010 THE PATIENT WAS EXPERIENCING PROBLEMS USING HIS LEGS. ONE MONTH LATER, PATIENT CONSULTED THE SURGEON. IN (B)(6) 2010, PATIENT UNDERWENT A FUSION PROCEDURE AT L4-L5, L5-S1 USING RHBMP-2/ACS OR PUREGEN. FOLLOWING THE SURGERY, PATIENT BEGAN TO SUFFER FROM PAIN IN HIS MID BACK AND IN HIS RIBS. IN (B)(6) 2011, PATIENT UNDERWENT A SPINAL FUSION AT C5-C6 USING RHBMP-2/ACS OR PUREGEN. DURING THIS SURGERY, PATIENT'S DIAPHRAGM WAS TORN WHEN THE CHEST TUBE WAS TAKEN OUT. IN (B)(6) 2011, PATIENT UNDERWENT AN INSTRUMENTAL FUSION PROCEDURE AT T7-T10 USING RHBMP-2/ACS OR PUREGEN. FOLLOWING THESE SURGERIES, PATIENT BEGAN EXPERIENCING NEW PAIN IN HIS RIGHT SIDE, BACK PAIN AND ULTIMATELY COULD NO LONGER WORK. IN (B)(6) 2012, PATIENT UNDERWENT A FORAMINOTOMY AND HEMILAMINECTOMY FROM C5-C7 USING RHBMP-2/ACS OR PUREGEN. SINCE THESE SURGERIES, PATIENT HAS BEEN UNABLE TO WORK AND CANNOT WALK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397249 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 Other