BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3455316 · Received November 7, 2013

    Report

    Report Number
    1030489-2013-04436
    Event Type
    Injury
    Date Received
    November 7, 2013
    Report Date
    August 29, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2003, THE PATIENT UNDERWENT A POSTERIOR FUSION AT L3-L4 USING RHBMP-2/ACS. POSTOPERATIVELY, IT IS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH CHRONIC PAIN, RADICULAR PAIN, AND EXCESS BONE GROWTH. THE PATIENT HAS ALLEGEDLY REQUIRED EXTENSIVE MEDICAL TREATMENT AND HAS NEVER RECOVERED FROM HIS SURGERY AND CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC DAILY ACTIVITIES OF LIVING. IT WAS REPORTED THAT THE PATIENT SUFFERED INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, AN INFLAMMATORY REACTION, HETEROTOPIC BONE GROWTH, OSTEOLYSIS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2003 THE PATIENT UNDERWENT: POSTERIOR SPINAL FUSION, L3, 4, 5; PLACEMENT OF XIA PEDICLE SCREW SYSTEM, L3, 4, 5; INTERBODY FUSION, L3-4 AND L4-5, VIA LEFT TRANSFORAMINAL LUMBAR INTERBODY APPROACH; PLACEMENT OF GLOBAL 11MM CAGES, LEFT OBLIQUE L3-4 AND L4-5, WITH BMP AND AUTOLOGOUS BONE GRAFT; RIGHT ILIAC CREST BONE GRAFT; LOCAL AUTOLOGOUS GRAFT AND ALLOGRAFT; EPIDURAL, LEFT L2-3; FOUR HOURS INTRAOPERATIVE NEUROPHYSIOLOGIC MONITORING WITH EMGS AND PEDICLE SCREWS CHECKED WITH NUVASIVE SYSTEM. PREOPERATIVE DIAGNOSIS: DEGENERATIVE DISCS AT L3-4 AND L4-5; LEFT GREATER THEN RIGHT RADICULOPATHY. PER OP-NOTES: ¿THE RIGHT ILIAC CREST WAS APPROACHED THROUGH THE SAME MIDLINE. THE PERIOSTEUM WAS REFLECTED ON THE ILIAC CREST, AND IT WAS DECORTICATED WITH A GOUGE. GOUGE AND CURETTES WERE USED TO HARVEST CORTICAL CANCELLOUS MATERAL WHICH WAS MORCELLIZED ON THE BACK TABLE AND MIXED WITH ALLOGRAFT, A LARGE BMP WAS MIXED ON THE BACK TABLE, ALSO. THE ILIAC CREST WAS IRRIGATED WITH JET LAVAGE CONTAINING GENTAMICIN AND GELFOAM APPLIED. THE PERIOSTEUM WAS REAPPROXIMATED, AND ATTENTION WAS TURNED TO THE MIDLINE INCISION¿. A MIXTURE OF ALLOGRAFT AND AUTOGRAFT WAS APPLIED PLUS HALF OF A BMP ROLL. ON THE BACK TABLE, THE GLOBAL 11MM CAGES WERE PACKED WITH A ROLL OF BMP AND AUTOLOGOUS BONE GRAFT. THESE WERE PLACED WITH THE HEIGHT TRANSVERSE IN ORDER TO MINIMIZE THE TRACTION ON THE NERVE ROOT. THE POSTEROLATERAL GRAFTING WAS NEXT PLACED WITH BMP AND A MIXTURE OF ALLOGRAFT AND AUTOLOGOUS GRAFT.¿ ON (B)(6) 2004 THE PATIENT UNDERWENT: INCISION AND DEBRIDEMENT LUMBAR SUPERFICIAL WOUND INFECTION; ASPIRATION OF DEEP LUMBAR PARASPINAL TISSUES AND CULTURING. PREOPERATIVE DIAGNOSIS: LUMBAR WOUND INFECTION, SUPERFICIAL, RULE OUT DEEP; STATUS POST LUMBAR FUSION (B)(6) 2003.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LATERAL INTERBODY FUSION USING RHBMP-2/ACS. SOMETIME APPROXIMATELY 2004, IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH CHRONIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575142 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 28 YR Required Intervention