BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1841196 · Received September 13, 2010

    Report

    Report Number
    1030489-2010-01197
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    April 17, 2006
    Report Date
    August 18, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE CITATION: MCCLELLAND, ET AL. VERTEBRAL BONE RESORPTION AFTER TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH BONE MORPHOGENETIC PROTEIN (RHBMP-2). J. SPINAL DISORD TECH. 2006; VOLUME 19, NUMBER 7: PP483-486. A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED WITHOUT ADDITIONAL DEVICE INFORMATION. WITHOUT RETURN OF THE DEVICE OR ASSOCIATED RECORDS IT IS NOT POSSIBLE TO ASCERTAIN A CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BONE RESORPTION WAS NOTED AFTER TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) WITH POSTERIOR INSTRUMENTATION, AND RHBMP-2/ACS PLACED WITHIN AND ADJACENT TO AN INTERBODY CAGE. PEDICLE SCREW AND BILATERAL ROD CONSTRUCT WERE USED. PRIOR TO SURGERY, THE PATIENT(S) WERE EVALUATED FOR 1-LEVEL OR 2-LEVEL DEGENERATIVE DISC DISEASE WITH OR WITHOUT RADICULOPATHY. THE PATIENT(S) HAD PREVIOUSLY FAILED CONSERVATIVE MANAGEMENT. COMPUTED TOMOGRAPHY (CT) STUDIES WERE PERFORMED AT A MINIMUM OF THREE MONTHS POST IMPLANT. IN SEVEN LEVELS THE CT STUDIES SHOWED MILD OSTEOLYTIC DEFECTS, DEFINED AS BONE RESORPTION LESS THAN 25% OF THE AREA OF THE INTERBODY IMPLANT. THE NUMBER OF PATIENTS WAS NOT STATED. NO DETAILS OR OTHER OUTCOMES WERE MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT INFUSE BONE GRAFT NEK MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability