BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3072760 · Received April 23, 2013

    Report

    Report Number
    1030489-2013-01224
    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

    DATE OF SURGERY: (B)(6) 2010, BEFORE END OF (B)(6) 2010, (B)(6) 2011 IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT EXTENSIVE LATERAL ENTRY SURGERY, IMPLANTED HARDWARE INTO THE SPINE. THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS. POST-OP, THE PATIENT BEGAN EXPERIENCING NEW, WORSE PAIN THAN PRIOR TO THE SURGERY. BEFORE THE END OF (B)(6) 2010, THE PATIENT UNDERWENT A SECOND EXTENSIVE SURGERY ON THORACIC SPINE THAT REQUIRED THE INSTALLATION OF SEVERAL PIECES OF HARDWARE ("THE SECOND SURGERY" THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS. IN (B)(6) 2011, THE PATIENT UNDERWENT CORRECTIVE SURGERY TO REPAIR SURGICAL MISTAKES AND FAILED HARDWARE FROM THE FIRST AND SECOND SURGERIES ("THE THIRD SURGERY") THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS. THE PATIENT OBTAINED NO RELIEF, THE CONDITION CONTINUED TO WORSEN. PRIOR TO DEATH, THE PATIENT WAS PERMANENTLY HARMED, LARGELY IM MOBILE, AND IN CONSTANT PAIN AS THE RESULT OF THESE SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173529 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