BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2183412 · Received July 28, 2011

    Report

    Report Number
    1030489-2011-00966
    Event Type
    Injury
    Date Received
    July 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: HELGESON ET AL. ADJACENT VERTEBRAL BODY OSTEOLYSIS WITH BONE MORPHOGENETIC PROTEIN USE IN TRANSFORAMINAL LUMBAR INTERBODY FUSION. THE SPINE JOURNAL 2011; 11:507-510. (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. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PUBLICATION THAT 23 PATIENTS (39 LEVELS TREATED) UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH RHBMP-2/ACS AND INTERBODY DEVICES. ALL PATIENTS OBTAINED A CT SCAN WITHIN 48 HOURS OF SURGERY, 3-6 MONTHS POSTOPERATIVELY, AND 2-1 YEARS POSTOPERATIVELY. THE 39 INDIVIDUAL LEVELS PERFORMED WERE DIVIDED AS FOLLOWS: 16 L5-S1, 16 L4-L5, 6 L3-L4 AND 1 L2-L3. TWELVE PATIENTS UNDERWENT A TLIF AT ONLY ONE LEVEL, 6 PATIENTS UNDERWENT 2-LEVEL TLIFS AND 5 PATIENTS UNDERWENT 3-LEVEL TLIFS. 78 VERTEBRAL BODIES/END PLATES WERE ASSESSED FOR OSTEOLYSIS (39 LEVELS). THE INCIDENCE OF OSTEOLYSIS 3 TO 6 MONTHS POSTOPERATIVELY IN ADJACENT VERTEBRAL BODIES WAS 54%. COMPARATIVELY, THE INCIDENCE AT 1 AND 2 YEARS WAS 41%. 24% OF PATIENTS HAD RESOLUTION OF THEIR OSTEOLYSIS FROM THE SHORT TERM TO INTERMEDIATE-TERM FOLLOW-UP PERIOD. ALTHOUGH NOT STATISTICALLY SIGNIFICANT, THE MEAN VOLUME OF OSTEOLYSIS WAS LESS AT 1 TO 2 YEARS, COMPARED WITH 3 TO 6 MONTHS. THE AREA OR RATE OF OSTEOLYSIS DID NOT APPEAR TO AFFECT THE RATE OF FUSION AS THERE WAS NO DIFFERENCE IN THE FUSION RATE BETWEEN THE PATIENTS WITH EVIDENCE OF OSTEOLYSIS AND THOSE WITHOUT. ADDITIONALLY, THERE WAS NO CORRELATION BETWEEN THE OSTEOLYSIS AND THE PRESENCE OF FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR