BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3073045 · Received April 23, 2013

    Report

    Report Number
    1030489-2013-01246
    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)(6). (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

    IMPLANT DATE: (B)(6) 2008; (B)(6) 2008 IT WAS REPORTED THAT ON (B)(6), 2008, THE SURGEON PERFORMED SPINAL FUSION SURGERY AT L5-T12 AND INSERTED TWO RODS AND MULTIPLE SCREWS (THE "FIRST SURGERY''). RHBMP-2/ACS WAS IMPLANTED IN THE PATIENT DURING THE SURGERY. FOLLOWING THE FIRST SURGERY, PATIENT'S BACK PAIN BECAME MORE SEVERE. ALTHOUGH HER BACK PAIN PRIOR TO THE FIRST SURGERY WAS INTERMITTENT, THE PAIN AFTER THE SURGERY BECAME EXTREME AND CONSTANT. ALSO FOLLOWING THE FIRST SURGERY, PATIENT BEGAN EXPERIENCING PAIN IN OTHER PARTS OF HER BODY WHERE PAIN DID NOT EXIST BEFORE, AS IN HER HIPS AND KNEES. ON (B)(6) 2008, THE SURGEON RECOMMENDED AND PERFORMED AN OSTEOTOMY OF PATIENT'S FEMUR AND INSERTED A ROD AND SCREWS (THE "SECOND SURGERY"). RHBMP-2/ACS WAS IMPLANTED IN THE PATIENT DURING THE KNEE REPLACEMENT SURGERY, IN CONTRADICTION TO WHAT WAS APPROVED BY THE FDA. FOLLOWING THE SECOND SURGERY, THE PATIENT HAD 18 MONTHS OF PHYSICAL THERAPY, WHILE HER BACK PAIN CONTINUED TO BECOME MORE SEVERE. THE PATIENT NOW TREATS WITH A DIFFERENT DOCTOR FOR THE SEVER BACK, HIP, AND KNEE PAIN THAT SHE DEVELOPED, AND CONTINUES TO THIS DAY TO EXPERIENCE, FOLLOWING THE TWO SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173838 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