BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3072976 · Received April 23, 2013

    Report

    Report Number
    1030489-2013-01239
    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)

    Additional Manufacturer Narrative · 1

    BRAND NAME: UNKNOWN HARDWARE, INFUSE BONE GRAFT. (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 PATIENT BEGAN TO EXPERIENCE LOWER BACK PAIN APPROXIMATELY 20 YEARS AGO. IN 2009, PATIENT VISITED AN IMAGING CENTER FOR HER BACK PAIN. AN MRI WAS PERFORMED THAT SHOWED A HERNIATION, BUT HER DOCTOR TOLD HER THAT SHE DID NOT NEED SURGERY. PATIENT TRIED SEVERAL INJECTIONS TO RELIEVE HER PAIN BUT THEY DID NOTHING NOR DID THEY HELP WITH HER RIGHT LEG VING OUT INTERMITTENTLY. IN (B)(6) 2009, PATIENT UNDERWENT SURGERY ON HERNIATED SPINE. THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS. POST-OP, PATIENT ALLEGED HER PAIN HAD GONE WORSE AND IS UNABLE TO RETURN TO HER WORK. ON (B)(6) 2010, PATIENT UNDERWENT A REVISION SURGERY. THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS. AFTER THE SECOND SURGERY, PATIENT HAD THREE SCREWS AND FOUR RODS IN HER BACK. PATIENT WAS ONLY ABLE TO RETURN PART-TIME TO WORK AFTER THE SECOND SURGERY. PRIOR TO PATIENT'S APPOINTMENT IN (B)(6) 2012, PATIENT ALLEGED OF HAVING SLIGHT SHOULDER PAIN, HEADACHES, AND A STIFF NECK. A CERVICAL MRI WAS TAKEN WHICH REVEALED A HERNIATED DISC. ON (B)(6) 2012, PATIENT UNDERWENT SURGERY ON CERVICAL SPINE. THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS. PATIENT ALLEGED OF NOW UNABLE TO WORK AT ALL AND WILL NEVER WORK AGAIN BECAUSE OF THE HARM CAUSED BY THE SURGERIES.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175320 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