BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2931755 · Received January 28, 2013

    Report

    Report Number
    1723170-2013-00058
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE TROUBLE-SHOOTING AT THE SITE, REPORTED THAT THE SURGEON CONFIRMED ACCURACY SEVERAL TIMES. WHEN GOING INTO THE PEDICLE THE SURGEON ALLEGED AN INACCURACY, CHECKED AND WAS ACCURATE. IT APPEARED THE PATIENT ANATOMY AND DEGREE OF SCOLIOSIS AFFECTED THE SURGEON'S CONFIDENCE IN NAVIGATION WITH SUCH DEFORMITY. ALL THE SCREWS PLACED IN THE PATIENT WERE GOOD. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS UNABLE TO OBTAIN THE SYSTEM ARCHIVES; THEREFORE, UNABLE TO DETERMINE ROOT CAUSE WITHOUT FURTHER INFORMATION OR TROUBLESHOOTING.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN INACCURACY THAT OCCURRED WHILE IN A SPINE PROCEDURE. THE SURGEON DISCONTINUED THE USE OF THE STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM; THEN NAVIGATED ON LEVEL 1 WITH THE FRAME ON THE VERTEBRAL BODY, AND STATED THAT HE WAS INACCURATE WHEN USING THE NON-NAVIGATED FEELER BALL TIP PROBE IN ADVANCE OF THE SCREW. A SECOND SURGEON IN THE ROOM CONTINUED TO USE NAVIGATION AND PLACED TWO MORE NAVIGATED SCREWS CONFIRMING ACCURATE PLACEMENT WITH THE C-ARM. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37477 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR