BEUDAMED
    FDA Adverse Event Other Summary report: N

    AFT - 1 DIVERTED TUBE

    MDR report key: 1006848 · Received February 25, 2008

    Report

    Report Number
    2249062-2008-00005
    Event Type
    Other
    Date Received
    February 25, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 25, 2007
    Manufacturer
    MFT
    Product Code
    MBP
    PMA / PMN Number
    K060161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A FILL TUBE TIP BROKE OFF INSIDE THE MESH DURING A 2-LEVEL FUSION CASE. THE FIRST MESH WAS PLACED AND FILLED AT L5-S1, AND ONLY A SMALL AMOUNT OF GRAFT WAS EXPELLED FROM THE FINAL TUBE. WHEN THE L4-L5 MESH WAS READY FOR FILLING, THAT PARTIAL TUBE WAS INTRODUCED FIRST. WHEN THE DR BEGAN TO EXPEL BONE IN THE MESH THE TIP BROKE. THEY REMOVED THE MESH, THE TUBE AND THE TIP, AND THE BONE AND PLACED A NEW MESH. FILLING WAS COMPLETED WITHOUT A PROBLEM AND IT WAS REPORTED THAT THE DR WAS VERY PLEASED WITH THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFT - 1 DIVERTED TUBE BONE VOID FILLER MBP MFT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE MEDWATCH #: 2249062-2008-00004