BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2201836 · Received August 5, 2011

    Report

    Report Number
    1723170-2011-01244
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REP TESTED SYSTEM AFTER SURGERY AND COULD NOT REPLICATE THE ISSUE AND FOUND THE SYSTEM FUNCTIONED ACCURATELY. SURGEON ACKNOWLEDGED HAMMERING ON PAK NEEDLE TO GO THROUGH CORTEX BONE AND NOT VERIFYING PAK NEEDLE THROUGH REMAINDER OF THE SURGERY. MEDTRONIC REP INSTRUCTED SURGEON ON PROPER PROCEDURE TO SUSTAIN GEOMETRY. SOFTWARE INVESTIGATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A SURGEON REPORTED AN ALLEGED AN INACCURACY DURING A THORACIC SPINE PROCEDURE WITH THE STEALTHSTATION S7, WHICH MAY HAVE CONTRIBUTED TO MISPLACE SCREWS THAT NEEDED TO BE REVISED AT A LATER DATE. THE SURGERY WAS COMPLETED WITH THE USE OF THE STEALTHSTATION S7 SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention O-ARM 1000 IMAGING SYSTEM