BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3041610 · Received April 8, 2013

    Report

    Report Number
    1723170-2013-00262
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IDENTIFIER AND WEIGHT ARE NOT AVAILABLE FROM THE SITE. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE TESTED THE ACCURACY OF THE SYSTEM ON SITE. NO ISSUES WERE FOUND. SYSTEM PERFORMED PROPERLY DURING TESTING.

    Description of Event or Problem · 1

    A MEDTRONIC (B)(4) REPRESENTATIVE REPORTED A POST OP CT SHOWING 2 MISPLACED SCREWS AFTER A NAVIGATED SPINE PROCEDURE. THE SCREWS WERE MISPLACED ON C7 AND T1 ON PATIENT'S RIGHT SIDE. VERTEX MAX WAS USED FOR THE PROCEDURE. NAVIGATION WAS BASED ON PRE-OPERATIVE CT SCAN. SURGEON CONFIRMED THEY USED FLUOROSCOPY DURING THE CASE. FOR THE PROCEDURE, THEY NAVIGATED THE DRILL GUIDE, THE CERVICAL PEDICLE FINDER AND A POINTER. THE SCREWS WERE NOT NAVIGATED AS THEY DON'T HAVE A NAVIGATED SCREWDRIVER FOR VERTEX MAX SCREWS. THE SCREWS ARE MISPLACED BUT TOTALLY ASYMPTOMATIC FOR THE PATIENT. NO ADDITIONAL SURGERY NEEDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143552 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR