BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3922661 · Received July 9, 2014

    Report

    Report Number
    1030489-2014-03162
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN IN HIS LOWER BACK AND LEG. (B)(6) 2010: THE PATIENT UNDERWENT A LUMBAR FUSION SURGERY WHERE RHBMP-2/ACS WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT FELL AND WAS TOLD HE WOULD REQUIRE NECK SURGERY TO CORRECT HIS NECK. (B)(6) 2010: THE PATIENT UNDERWENT A CERVICAL FUSION SURGERY WHERE RHBMP-2/ACS IMPLANTED. (B)(6) 2011: THE PATIENT UNDERWENT A LUMBAR FUSION SURGERY. THE PATIENT NOW EXPERIENCES PAIN IN HIS LEGS, ARMS, HANDS, FEET AND IN HIS LOWER BACK. THE PATIENT NOW REQUIRES NARCOTICS TO FUNCTION AND MUST WALK WITH A CANE. THE PATIENT'S POSTOPERATIVE PERIOD WAS MARKED BY PAIN. IMAGING STUDIES SHOWED THAT THE PATIENT HAD DEVELOPED UNCONTROLLED BONE GROWTH AND RESULTING NERVE IMPINGEMENT AT THE SITE OF IMPLANT. THE PATIENT CONTINUES TO HAVE BONE OVERGROWTH CAUSING NERVE IMPINGEMENT, AND CHRONIC PAIN.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS IN THE SURGERY OF (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401103 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