BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3872671 · Received June 13, 2014

    Report

    Report Number
    1030489-2014-02754
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: LAMMLI ET AL. STAND-ALONE ANTERIOR LUMBAR INTERBODY FUSION FOR DEGENERATIVE DISC DISEASE OF THE LUMBAR SPINE: RESULTS WITH A TWO YEAR FOLLOW UP. SPINE. DOI: 10.1097/BRS.0000000000000393. MEAN AGE 43 ± 10 YEARS; 69 FEMALES, 49 MALES. MEAN WEIGHT 180.2 ± 39.6 POUNDS. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT THE AUTHORS CONDUCTED A RETROSPECTIVE CHART REVIEW OF A CONSECUTIVE SERIES OF PATIENTS DIAGNOSED WITH DEGENERATIVE DISC DISEASE BETWEEN L4 AND S1, TREATED WITH STAND ALONE ANTERIOR LUMBAR INTERBODY FUSION (ALIF, EITHER ONE OR TWO-LEVEL) AND USE OF RHBMP-2 FOR BONY FUSION WITH INSTRUMENTED FIXATION. A 118 PATIENTS MET INCLUSION CRITERIA.THE PROCEDURE USED THE FOLLOWING: AN ANTERIOR PLATE WITH 4 SCREWS (ATB PLATE), AN INTEGRATED CAGE/PLATE DEVICE WITH 4 SCREWS (SYNFIX-LR), AND/OR AN INTERBODY CAGE/SPACER (EITHER SYNTHES PEEK CAGE, SYNTHES BP LORDOTIC CAGE, AR SPACER, OR FRA SYNTHES DISTRACT), ONE OR TWO SPONGES OF RHBMP-2, AND AUTOGRAFT. NO PATIENTS EXPERIENCED INTRA-OPERATIVE OR MAJOR COMPLICATIONS. TWO PATIENTS WERE TREATED FOR HEMATOMA POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349284 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 00043 YR