BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1982293 · Received February 9, 2011

    Report

    Report Number
    1030489-2011-00104
    Event Type
    Injury
    Date Received
    February 9, 2011
    Report Date
    January 12, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KNOX, JEFFREY B. ET AL. "OSTEOLYSIS IN TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH BONE MORPHOGENETIC PROTEIN-2". SPINE (PHILA PA 1976) 2011: JAN 5 D11. INTERBODY CAGE - THERAPY DATES NOT REPORTED. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THE IMAGING FILM IN THE LITERATURE ARTICLE SHOWS SIGNS OF OSTEOLYSIS AND LOSS OF BONE STOCK AROUND THE IMPLANT. 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

    THE RESULTS OF A RETROSPECTIVE STUDY OF PATIENTS WHO UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) BETWEEN (B)(6) 2004 AND (B)(6) 2009 WERE REPORTED. THE SURGICAL PROCEDURES WERE PERFORMED BY A SINGLE SURGEON AND INVOLVED EITHER SINGLE LEVEL OR TWO LEVEL FUSIONS. THE PATIENTS HAD PRESENTED WITH DEGENERATIVE SPINAL CONDITIONS (SPONDYLOLISTHESIS, DISCOGENIC BACK PAIN, AND/OR LUMBAR RADICULOPATHY) AND WERE GREATER THAN (B)(6). THE PATIENTS UNDERWENT A TLIF WITH PEDICLE SCREW INSTRUMENTATION THROUGH EITHER A MIDLINE POSTERIOR OR MINIMALLY INVASIVE APPROACH. AN INTERBODY DEVICE WAS FILLED WITH RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RH-BMP2) SPONGES AND LOCAL AUTOGRAFT. A STANDARD DOSE OF 5 MG OF RH-BMP-2 WAS USED. THE PATIENTS WERE DISCHARGED FROM HOSPITAL DAY THREE POST-OP. LOW IMPACT ACTIVITIES WERE PERMITTED. STRENUOUS PHYSICAL ACTIVITY AND HEAVY LIFTING WERE NOT PERMITTED UNTIL SIX WEEKS POST-OP. ONE PATIENT WHO UNDERWENT TWO LEVEL TLIF DEMONSTRATED ONE LEVEL OF MODERATE OSTEOLYSIS AND ONE LEVEL OF SEVERE OSTEOLYSIS THREE MONTHS POST-OP WITHOUT EVIDENCE OF GRAFT SUBSIDENCE OR CAGE MIGRATION. NEITHER LEVEL DEMONSTRATED WORSENING OSTEOLYSIS ON SUBSEQUENT FOLLOW UP-IMAGING. REVISION SURGERY WAS NOT REQUIRED DURING STUDY PERIOD DUE TO OSTEOLYSIS.

    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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1