BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAXANO IO-FLEX WIRE (PACKAGED WITH IO-NCW)

    MDR report key: 2474393 · Received January 10, 2012

    Report

    Report Number
    3006324586-2012-00002
    Event Type
    Other
    Date Received
    January 10, 2012
    Date of Event
    December 21, 2011
    Report Date
    January 10, 2012
    Manufacturer
    BAXANO, INC.
    Product Code
    HAE
    PMA / PMN Number
    K100958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT LUMBAR DECOMPRESSION SURGERY. AFTER PERFORMING SURGICAL ACCESS TO THE EPIDURAL SPACE AT L3/4, THE BAXANO PROBE WAS USED TO GAIN ACCESS TO THE RIGHT L3/4 FORAMEN. THE BAXANO WIRE WAS PASSED THROUGH THE FORAMEN SO THAT IT EXITED OUT THE SKIN LATERAL TO THE INCISION. THE BAXANO NEUROCHECK DEVICE WAS USED TO LOCALIZE THE NERVE ROOT, AND THE CURRENT THRESHOLD READINGS OBTAINED FROM THE NEUROMONITORING SYSTEM WERE NOT FAVORABLE. THE NEUROCHECK DEVICE WAS DETACHED FROM THE WIRE AND REMOVED. THE SURGEON REMOVED THE WIRE BY PULLING IT OUT LATERALLY THROUGH THE SKIN INCISION AND PREPARED TO REDEPLOY THE PROBE. AT THIS TIME A PINHOLE DUROTOMY WAS OBSERVED AND WAS THOUGHT TO BE CAUSED BY THE BALL TIP OF THE WIRE COMING IN CONTACT WITH THE DURA. DURASEAL WAS USED TO REPAIR THE DURA AND THERE WERE NO FURTHER COMPLICATIONS REPORTED POSTOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXANO IO-FLEX WIRE (PACKAGED WITH IO-NCW) ACCESSORY TO MANUAL RONGEUR HAE BAXANO, INC. IO-NCW 100228

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other