BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3171028 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02297
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 16, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 2002 THE PATIENT UNDERWENT AN UNSPECIFIED SURGERY USING RHBMP-2/ACS AND RODS. THE PATIENT HAS HAD MAJOR COMPLICATIONS SINCE THEN AND NOW HAS BEEN ADVISED TO HAVE ADDITIONAL SURGERY ON HIS THORACIC SPINE. THE PATIENT WAS NOT SURE WHAT IS WRONG, MENTIONED NERVE COMPRESSION. THE PATIENT REPORTED THAT HE HAS ¿ALL THE SYMPTOMS FROM THE ADS.¿ PER THE PATIENT, "MY PENIS WON¿T GET HARD ANYMORE AND I HAVE DIFFICULTY BREATHING- I MEAN SWALLOWING." THE PATIENT CANNOT HAVE AN ERECTION, IS UNABLE TO HAVE CHILDREN, AND ¿HAS THE BREATHING PROBLEMS.¿ PATIENT IS REPORTEDLY TOTALLY DISABLED AND CANNOT WORK. THE PATIENT THINKS THAT SOMETHING IN HIS BACK IS BROKEN BECAUSE IT POPS ALL THE TIME. THE PATIENT HAS DEBILITATING BACK PROBLEMS AND REPORTED ¿PAIN <(>&<)> SUFFERING¿. PATIENT HAS HAD NUMEROUS MRI EXAMS, BUT DOES NOT KNOW WHAT THE EXAMS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270705 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 Required Intervention