BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2013548 · Received February 3, 2011

    Report

    Report Number
    1723170-2011-00078
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    MEDTRONIC NAVIGATION. INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EVALUATED AT THE SITE. THE REPORTED ISSUE WAS ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. IT WAS NOTED THAT THE SHAFT THAT HOLDS THE PERC PIN IN PLACE WAS BENT WHICH ALLOWED UNWANTED MOVEMENT AND SLIPPING OF SPINE FRAME. THE DAMAGED SPINE FRAME WAS DIRECTLY RELATED TO THE REPORTED EVENT. A RMA WAS ISSUED TO REPLACE THE DAMAGED PART.

    Description of Event or Problem · 1

    A NEURO COORDINATOR, CALLED IN FROM THE SITE TO REPORT THAT THE SURGEON WAS INACCURATE BY 1CM WHILE NAVIGATING WITH AN O-ARM SPIN IN THE SYNERGY SPINE SOFTWARE. THEY HAD TO TAKE TWO ADD'L SPINS WITH THE SYSTEM TO MAINTAIN ACCURACY. THE SURGEON OPTED TO CONTINUE THE SURGERY USING THE STEALTHSTATION WITH NO IMPACT ON THE PT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR O-ARM 1000 IMAGING SYSTEM