BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3190401 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02535
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    August 29, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A STABILIZATION PROCEDURE AT T8-T9 RIGHT THORACOSCOPIC FUSION SURGERY USING RHBMP-2/ACS WITH A ZIMMER/SPINE TECH BAK CAGE. IT WAS REPORTED THAT IN (B)(6) 2006, THE PATIENT WAS SUBSEQUENTLY DIAGNOSED AS HAVING OSTEOPHYTE FORMATION (BONE GROWTH) ON THE RIGHT SIDE OF T8-T9. THIS OSTEOPHYTE CAUSED THE PATIENT PERSISTENT PAIN, BALANCE ISSUES, AND PARTIAL PARALYSIS. THE PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT AND ADDITIONAL SURGERIES ON OR ABOUT (B)(6) 2006 AND (B)(6) 2007 TO REMOVE OSTEOPHYTES. REPORTEDLY, THE PATIENT HAS NEVER RECOVERED FROM HER SURGERY INVOLVING RHBMP-2/ACS, AND SHE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HER FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290824 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 44 YR Required Intervention