BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3233078 · Received July 18, 2013

    Report

    Report Number
    1723170-2013-00527
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 18, 2013
    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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC ENGINEER CHECKED INTEGRITY OF O-ARM EXAM. ALL SLICES WERE PRESENT. EXAM LOADED CORRECTLY IN SYNERGY SPINE 2.0.1 SOFTWARE. ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    MEDTRONIC REPRESENTATIVE FOLLOW-UP INVESTIGATION CONFIRMED THAT A DEPUY SCREW SYSTEM WAS USED IN CONJUNCTION WITH A PT AND A NON-MEDTRONIC DRIVER. SOFTWARE INVESTIGATION HAS NOT BEEN COMPLETED AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT, DURING A L4-S1 LUMBAR SPINE PROCEDURE, THE SURGEON ALLEGED A 5MM INACCURACY LATERALLY WHILE NAVIGATING SCREW PLACEMENT WITH AN O-ARM. THE SPINE REFERENCE CLAMP WAS PLACED AT S1. THE SURGEON DEEMED THE INACCURACY WAS AT S1 AND ACCURATE AT ALL OTHER LEVELS. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333256 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR