BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXANO IO-FLEX NEURO CHECK DEVICE WITH WIRE

    MDR report key: 1568988 · Received December 29, 2009

    Report

    Report Number
    3006324586-2009-00015
    Event Type
    Injury
    Date Received
    December 29, 2009
    Date of Event
    November 30, 2009
    Report Date
    December 28, 2009
    Manufacturer
    BAXANO, INC.
    Product Code
    JXE
    PMA / PMN Number
    K092729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE SURGERY, THE SURGEON WAS UNSURE AS TO WHAT CAUSED THE DURAL TEAR (EITHER THE BAXANO PROBE, BAXANO NEURO CHECK DEVICE, BAXANO MICROBLADE SHAVER, OR THE NON-BAXANO MANUAL RONGEURS THAT WERE USED IN THE PROCEDURE). SINCE THE SURGEON CANNOT RULE OUT THE BAXANO DEVICES, WE ARE SUBMITTING INITIAL REPORTS FOR EACH POSSIBLE BAXANO DEVICE ( A TOTAL OF FOUR REPORTS, NUMBERS 3006324586-2009-0014 THROUGH - 0017).

    Description of Event or Problem · 1

    PT UNDERWENT LUMBAR DECOMPRESSION OF L4-5 AND L5-S1 LEVELS. PHYSICIAN DECOMPRESSED THE L4-5 LEVEL, AND THEN PROCEEDED TO THE L5-S1 LEVEL. THE RIGHT L5 NERVE ROOT WAS ACCESSED USING A BAXANO IPSI PROBE AND A 10MM MICROBLADE SHAVER (MBS) WAS INSERTED BUT COULD NOT BE ADVANCED. THE DEVICE WAS EXCHANGED FOR A 5.5MM MBS, AND DECOMPRESSION INITIATED. DELAMINATED CARTILAGE WAS REMOVED FROM THE AREA USING RONGEURS. AT THIS POINT, A SMALL DURAL TEAR WITH NO CSF LEAK WAS OBSERVED IN THE AXILLA OF THE L5 ROOT. THE NERVE WAS TESTED USING A MONOPOLAR CONTROL PROBE (NON-BAXANO) SHOWING RIGHT TIBIA AND GASTROC RESPONSE AT 1.5MA. A COTTONOID WAS PLACED TO SECURE THE FLAP OF THE TEAR. THE SURGEON WAS UNSURE AS TO WHAT CAUSED THE DURAL TEAR (BAXANO PROBE, NEURO CHECK DEVICE, MBS, OR NON-BAXANO MANUAL RONGEURS). POST SURGERY, THE PT WAS ABLE TO MOVE ALL LIMBS (INCLUDING FEET) WITH NO PAIN, WEAKNESS OR NUMBNESS. A BAXANO REP FOLLOWED UP WITH THE SURGEON IN 2009, WHO STATED THAT THE PT WAS EXPERIENCING NUMBNESS AND WEAKNESS OF THE RIGHT GREAT TOE. PT WAS SEEN IN FOLLOW-UP TEN DAYS LATER, AND REPORTED TO BE EXPERIENCING MILD WEAKNESS AND NUMBNESS IN HER RIGHT FOOT, INDICATIVE OF L5 NERVE ROOT INVOLVEMENT. PT FOLLOW-UP SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXANO IO-FLEX NEURO CHECK DEVICE WITH WIRE SURGICAL NERVE STIMULATOR/LOCATOR JXE BAXANO, INC. IO-NCW 09110403

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other