BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3230294 · Received July 16, 2013

    Report

    Report Number
    1723170-2013-00522
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    April 29, 2012
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE AS THIS INFORMATION WAS DERIVED FROM A JOURNAL ARTICLE, MODERATELY DISPLACED PEDICLE SCREW IN JOURNAL ARTICLE BY Y. ALLAM AND J. SILBERMANN. DATE OF EVENT IS AN APPROXIMATION DERIVED FROM THE JOURNAL ARTICLE, MODERATELY DISPLACED PEDICLE SCREW IN JOURNAL ARTICLE BY Y. ALLAM AND J. SILBERMANN, FIRST PUBLICATION DATE WAS APRIL 29, 2012. EVALUATION BY MEDTRONIC CLINICAL REPRESENTATIVE STATES: IT IS CLEAR FROM ARTICLE THAT THE REASON THIS PATIENT WAS NOT AFFECTED WAS THAT HE WAS ALREADY PARALYZED, PRESUMABLY BY TRAUMA THAT WAS THE OCCASION FOR THE SURGERY. SO SCREW WAS NOT MOVED. NOT SERIOUS FOR REASONS JUST MENTIONED. NO ALLEGATIONS WERE MADE OF MEDTRONIC NAVIGATION'S DEVICE CAUSING OR CONTRIBUTING TO THE PATIENT EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED FROM A PUBLISHED STUDY, ¿COMPUTER TOMOGRAPHY ASSESSMENT OF PEDICLE SCREW PLACEMENT IN THORACIC SPINE: COMPARISON BETWEEN FREE HAND AND A GENERIC 3D-BASED NAVIGATION TECHNIQUES¿ THE AUTHORS WHILE FINDING BETTER ACCURACY WITH THE O-ARM AND STEALTHSTATION FOR PEDICLE SCREW PLACEMENT, COMPARED TO FREE HAND, HAD ONE PATIENT IN THE NAVIGATED GROUP WHO SHOWED MEDIAL FRANK PENETRATION 3¿6 MM OF A THORACIC SCREW, WHICH HOWEVER DID NOT NEED TO BE MOVED BECAUSE THIS PRESUMABLE TRAUMA PATIENT HAD ¿COMPLETE CORD TRANSECTION DUE TO ROTATION INJURY OF TH5¿TH6.¿ THERE WAS NO SERIOUS INJURY TO THIS PATIENT DUE TO THE PATIENT ALREADY BEING PARALYZED. MEDTRONIC NAVIGATION, INC. IS FILING THIS MDR TO ENSURE VISIBILITY TO PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION S7 SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328991 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1