BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1080101 · Received July 17, 2008

    Report

    Report Number
    1030489-2008-00353
    Event Type
    Injury
    Date Received
    July 17, 2008
    Date of Event
    April 11, 2008
    Report Date
    June 18, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TWO-LEVEL PLIF AT L4-S1 USING RHBMP-2/ACS AND LOCAL BONE PACKED INTO TWO 10 X 22 MM PEEK SPACERS AT L4/5 AND TWO 10 X 22 MM SPACERS AT L5/S1. THE INTERBODY FUSION WAS SUPPLEMENTED WITH POSTERIOR FIXATION INSTRUMENTATION AND A THREE LAYER POSTEROLATERAL FUSION USING RHBMP-2/ACS, DEMINERALIZED BONE MATRIX, LOCAL BONE AND BONE MARROW ASPIRATE. CT SCAN PERFORMED AT AN UNKNOWN TIME POST-OP REPORTEDLY DEMONSTRATED SOLID INTERBODY FUSION. HOWEVER, THE PATIENT COMPLAINED OF INCREASING PAIN IN THE LOWER BACK AND LEFT LEG. CT/MYELOGRAM SHOWED BONE SPURS AT THE L5/S1 & L4/5 DISK SPACES. APPROXIMATELY, ELEVEN-MONTHS POST-OP, A SURGICAL INTERVENTION WAS REPORTEDLY PERFORMED TO REMOVE THE BONE FORMATIONS. THE PT IS REPORTEDLY DOING WELL POST-OP AT THIS TIME.

    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 M110605AAK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention