BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAXANO IO-FLEX MICROBLADE SHAVER

    MDR report key: 3020657 · Received March 21, 2013

    Report

    Report Number
    3006324586-2013-00005
    Event Type
    Other
    Date Received
    March 21, 2013
    Date of Event
    February 6, 2013
    Report Date
    March 21, 2013
    Manufacturer
    BAXANO, INC.
    Product Code
    HAE
    PMA / PMN Number
    K100958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS A (B)(6) MALE UNDERGOING L3-L5 DECOMPRESSION. FOLLOWING DECOMPRESSION AT L4/5 WITH THE 10MM BAXANO IO-FLEX MICROBLADE SHAVER, THE SURGEON NOTED A DURAL TEAR. THE TEAR WAS REPAIRED WITH DURAL SEALANT AND SUTURES AND THERE WERE NO FURTHER SEQUELAE. THE PT DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117707 BAXANO IO-FLEX MICROBLADE SHAVER RONGEUR, MANUAL HAE BAXANO, INC. IO-MBS10SC 100804

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other