BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXANO NEURAL LOCALIZATION PROBE

    MDR report key: 1341802 · Received March 9, 2009

    Report

    Report Number
    3006324586-2009-00003
    Event Type
    Malfunction
    Date Received
    March 9, 2009
    Date of Event
    February 10, 2009
    Report Date
    March 9, 2009
    Manufacturer
    BAXANO, INC.
    Product Code
    GZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS INSPECTED. MANUFACTURING AND MATERIAL RECORDS WERE EVALUATED AND COMPONENTS AND PROCESSES WERE WITHIN SPECIFICATION. WHILE NO PEBAX MATERIAL WAS MISSING, SEVERAL WIRE FRAGMENTS WERE STRETCHED AND SEVERED AS A RESULT OF THE MATERIAL SEPARATION. A CORRECTIVE ACTION WAS INITIATED TO EVALUATE DESIGN CONTRIBUTIONS TO THE MALFUNCTION.

    Description of Event or Problem · 1

    DURING A LUMBAR DECOMPRESSION, THE PHYSICIAN WAS USING THE BAXANO NEURAL LOCALIZATION PROBE LOCALIZE THE L5 NERVE ROOT. AFTER SUCCESSFULLY PASSING THE PROBE AND LOCALIZING THE L4/5 FORAMEN, THE PROBE WAS WITHDRAWN AND THE PHYSICIAN OBSERVED THAT THE CATHETER PORTION OF THE PROBE HAD SEVERED AND SLID DISTALLY OVER THE TIP. THE DEVICE REMAINED INTACT. IN 2009, THE COMPANY SPOKE TO THE PHYSICIAN. NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AS A RESULT OF THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXANO NEURAL LOCALIZATION PROBE NEURAL LOCALIZATION PROBE GZI BAXANO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR