BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3120883 · Received May 20, 2013

    Report

    Report Number
    1723170-2013-00362
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO ATTEND THE NEXT SURGERY TO PROVIDE TROUBLESHOOTING ASSISTANCE. THERE WERE NO ISSUES DETECTED AND THE POST-OP SPIN SHOWED THE SCREWS WERE PLACED EXACTLY WHERE THE SURGEON THOUGHT THEY SHOULD BE PLACED. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED A CASE OF INACCURACY WHERE THE SCREWS HAD TO BE REPOSITIONED. THE ISSUE ALLEGEDLY OCCURRED POST SOFTWARE UPGRADE. LATER IT WAS REPORTED BY A MEDTRONIC REPRESENTATIVE, WHO ATTENDED THE CASE, THAT THE SURGERY WAS AN L2-L3 TLIF AND 2 PLACED SPINE SCREWS HAD TO BE TAKEN OUT SINCE THEY WERE PLACED 3-5MM INACCURATE. NAVIGATION WAS CONTINUED USING NAVIGATED TAPS, SCREWS, AND THE UNIVERSAL DRILL GUIDE. THERE WAS NO HARM TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222147 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention