BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1002308 · Received February 22, 2008

    Report

    Report Number
    1030489-2008-00092
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    September 26, 2007
    Report Date
    January 24, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNK IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. POST-OPERATIVE CT SCANS WERE REVIEWED, WHICH DEMONSTRATED AN APPARENTLY AN ACCUMULATION OF FLUID WHICH DOES NOT COMMUNICATE WITH THE VERTEBRAL COLUMN OR DISK SPACES, AND APPEARS TO BE UNRELATED TO THE USE OF ANY MEDTRONIC PRODUCT. WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. NEVERTHELESS, WE ARE FILING THIS MEDWATCH FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SEVEN LEVEL ALIF FROM T11-S1 USING RHBMP-2/ACS, CANCELLOUS ALLOGRAFT CHIPS, GRAFTON AND OVOID TITANIUM MESH CAGES. THE PATIENT REPORTEDLY DEVELOPED A COLLECTION OF FLUID ANTERIOR TO THE VERTEBRAL COLUMN. THE COLLECTION OF FLUID REPORTEDLY RECURRED FOLLOWING TREATMENT, AND A CT GUIDED NEEDLE ASPIRATION WITH INSERTION OF PIG-TAIL WAS PERFORMED APPROXIMATELY NINE WEEKS POST-OP DURING WHICH APPROXIMATELY 250CC OF SEROUS FLUID WAS DRAINED. GELFOAM WAS COATED OVER THE SURFACE OF THE ANTERIOR VERTEBRAL COLUMN FROM T11-S1. GRAFTON AND ALLOGRAFT CHIPS WERE IMPLANTED WITHIN THE INTERBODY DEVICES.

    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 56 YR Required Intervention