BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3922700 · Received July 9, 2014

    Report

    Report Number
    1030489-2014-03164
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 18, 2014
    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). EITHER 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 IN (B)(6) 2007, THE PATIENT UNDERWENT A SEGMENTAL SPINAL FIXATION TO CORRECT SCOLIOSIS AND KYPHOSIS WHERE RHBMP-2/ACS WAS IMPLANTED. POST-OPERATIVELY, THE PATIENT EXPERIENCED PAIN THAT WAS MUCH WORSE THAN WHAT HE HAD BEFORE THE SURGERY. THE PATIENT WAS TOLD THE MUSCLES NEEDED TIME AND PHYSICAL THERAPY. AFTER SOME TIME AND PHYSICAL THERAPY, THE PATIENT STILL EXPERIENCED UNBEARABLE PAIN. THE PATIENT MUST TAKE PAIN MEDICATION TO FUNCTION AND ALSO REPORTS ANXIETY AND DEPRESSION. 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 SUFFER FROM BONE OVERGROWTH CAUSING NERVE IMPINGEMENT, AND CHRONIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402076 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