BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4140722 · Received October 3, 2014

    Report

    Report Number
    1030489-2014-03811
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    July 11, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL AND POSTERIOR LUMBAR FUSION AT L5-S1 USING RHBMP-2/ACS, COMBINED WITH AUTOGRAFT AND ALLOGRAFT, PLACED INSIDE OF AN INTERBODY CAGE. FOLLOWING THE SURGERY, THE PATIENT DEVELOPED FURTHER BACK PAIN AND LEFT LEG PAIN. THE PATIENT UNDERWENT ADDITIONAL IMAGING. A CT SCAN DATED (B)(6), 2008 DEMONSTRATED THAT THE PATIENT HAD DEVELOPED CYST FORMATION AND ECTOPIC BONE GROWTH. THE PATIENT REQUIRED AN ADDITIONAL SURGERY TO REMOVE INSTRUMENTATION AND REMOVE THE ECTOPIC BONE GROWTH ON (B)(6) 2010. ADDITIONALLY, THE PATIENT UNDERWENT AN ADDITIONAL FUSION SURGERY ON (B)(6), 2011. THE PATIENT HAS NEVER RECOVERED FROM HIS SURGERY, AND HE HAS DAILY, DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619845 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M115002AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention