BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3072504 · Received April 23, 2013

    Report

    Report Number
    1030489-2013-01200
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT 'MEDICALLY UNNECESSARY, EXPERIMENTAL' SPINE SURGERIES WHERE CERVICAL AND THORACIC RODS, SCREWS, CAGES AND RHBMP-2/ACS WERE IMPLANTED. THE PATIENT HAS SUSTAINED INJURY WITHIN THE PAST FOUR YEARS. THE PATIENT HAS ALLEGEDLY UNDERGONE RELATED FOLLOW UP CARE, PHYSICAL THERAPY, PRESCRIPTIONS, INJECTIONS, AND IMAGE STUDIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2003, PATIENT WOKE UP WITH A DULL DEEP PAIN IN HIS BACK; HE WAS (B)(6) AT THE TIME. PATIENT UNDERWENT MRI FOR THE SAME. PATIENT ATTEMPTED VARIOUS TREATMENTS INCLUDING PHYSICAL THERAPY, WATER THERAPY, AND ACUPUNCTURE. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT INJECTION TREATMENT (STEROID INJECTIONS). IN 2005, PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND WAS TAKEN TO A FACILITY, WHERE HE HAD AN MRI AND X-RAYS TAKEN. PATIENT'S PAIN BECAME MORE INTENSE AS A RESULT OF THE COLLISION. PRIOR TO SURGERY, PATIENT WAS DIAGNOSED WITH TWO HERNIATED DISCS, WHICH WERE PRESSING ON HIS NERVES. THE SURGERY WAS TO CORRECT THIS ISSUE BY REMOVING THE HERNIATED DISCS AND FUSING THE VERTEBRAE USING CADAVER DISKS. THE PATIENT UNDERWENT BACK SURGERY ON (B)(6) 2005 AND REPLACED THE HERNIATED DISCS WITH ARTIFICIAL DISCS. THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS. PATIENT WAS A MINOR AT THE TIME OF SURGERY. POST-OP, PATIENT REPORTED THAT HIS BACK PAIN GOT WORSE. DURING THE SECOND POST-OPERATIVE APPOINTMENT, PATIENT WAS STILL IN PAIN AND ASKED FOR HELP. IN (B)(6) 2007, PATIENT HAD ANOTHER MRI AND X-RAYS TAKEN. PATIENT ALLEGED THAT THE PAIN IS SO DEBILITATING THAT HE WORKS WITH THE RESTRICTIONS OF NO LIFTING, MUST SIT EVERY FEW HOURS, AND IS UNABLE TO PICK-UP OR PLAY WITH HIS CHILDREN.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT AN INSTRUMENTED T11-T12 AND T12-L1 SPINAL FUSION WITH BMP-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173292 UNKNOWN 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