BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 5680735 · Received May 25, 2016

    Report

    Report Number
    1723170-2016-00981
    Event Type
    Injury
    Date Received
    May 25, 2016
    Date of Event
    April 28, 2016
    Report Date
    May 25, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL PATIENT IDENTIFIER WAS "(B)(6)" WHICH WOULD NOT FIT IN THE FIELD DUE TO CHARACTER LIMITATIONS. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS UNRELATED TO A SOFTWARE ISSUE. PER THE REPORTED EVENT THIS WAS NOT A FAILURE. THE BREACH THAT OCCURRED WAS DISPLAYED ON THE NAVIGATION SOFTWARE CORRECTLY. THE SOFTWARE FUNCTIONED AS DESIGNED. THE MOST LIKELY CAUSE WAS OPERATOR TECHNIQUE AND PATIENT ANATOMY. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED A MEDTRONIC NAVIGATION SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT THE NAVIGATION SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINE FUSION THE SURGEON INFERIORLY BREACHED THE VERTEBRAL BODY OF T1 WHILE PLACING A NAVIGATED SCREW. THE NAVIGATION SOFTWARE CORRECTLY REPRESENTED A BREACH TRAJECTORY WHILE USING THE NAVIGATED DRILL BIT. BECAUSE OF THE INSTABILITY OF THE CERVICAL ANATOMY AND THE PRESSURE APPLIED BY THE DRILL BIT, IT WAS DIFFICULT FOR THE SURGEON TO UNDERSTAND THE ACTUAL PATH CREATED UNTIL THE IMPLANT WAS PLACED. THE SURGEON REMOVED THE SCREW AND SUCCESSFULLY COMPLETED THE SURGERY. AFTER EXPLAINING THE SITUATION, DR. KIM SEEMED TO UNDERSTAND WHAT HAD HAPPENED AND USED THE INFORMATION THROUGHOUT THE REST OF THE SURGERY. THERE WAS NO NEGATIVE IMPACT TO THE OUTCOME OF THE PATIENT. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED A MEDTRONIC NAVIGATION SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT THE NAVIGATION SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332521 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention