BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1910790 · Received November 23, 2010

    Report

    Report Number
    1723170-2010-00066
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER SITE REP, HOSPITAL COULD NOT PROVIDE PT WEIGHT. THE SYS WAS EVALUATED AT THE SITE. THE ACCURACY WAS FOUND TO BE LESS THAN OR EQUAL TO 2.0MM. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SYS WAS FULLY FUNCTIONAL AND THE SYS CHECKOUT SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT DURING A SURGERY THEY HAD AN INACCURACY OF 4-6MM. THERE WERE INACCURACIES AT ALL LEVELS FOUND AT POST-OP SPIN USING ALL NAVIGATED INSTRUMENTS. A SECOND SURGERY WAS NOT REQUIRED AS THE DOCTOR WAS ABLE TO REPOSITION THE SCREWS WITH REGULAR FLUORO DURING SURGERY. THE CASE WAS COMPLETED USING THE STEALTHSTATION. THE PT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention O-ARM 1000 IMAGING SYSTEM