BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1893118 · Received October 29, 2010

    Report

    Report Number
    1030489-2010-01407
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    April 6, 2009
    Report Date
    October 13, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE CITATION: RIHN, ET AL. COMPLICATIONS ASSOCIATED WITH SINGLE-LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION. THE SPINE JOURNAL. 2009; 9: 623-629. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. 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

    THE RESULTS OF A RETROSPECTIVE, (B)(4) OF 86 PATIENTS BETWEEN THE AGES OF 18 AND 80 YEARS, WERE REVIEWED. BETWEEN JANUARY 2004 TO MAY 2007, THE PATIENTS UNDERWENT SINGLE-LEVEL TLIF PROCEDURES USING RHBMP-2 FOR THE TREATMENT OF A DEGENERATIVE CONDITION. THE DIFFERENCE IN COMPLICATIONS OBSERVED WITH THE USE OF ILIAC CREST AUTOGRAFT COMPARED WITH RHBMP-2 WAS ASSESSED. TWO PATIENT'S DEVELOPED LUMBAR INFECTIONS. FROM THE DATA PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE TIME OF ONSET, ORGANISM, INTERVENTION, OR COURSE OF ANTIBIOTICS.

    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 Required Intervention