BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 1934557 · Received November 23, 2010

    Report

    Report Number
    1723170-2010-00102
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 29, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED BY DOWNGRADING THE O-ARM SOFTWARE TO 3.1.0 AND RE-CALIBRATING THE SYSTEM.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SURGEON ALLEGED AN INACCURACY OF 1MM TO 3MM DURING A LUMBAR SPINE CASE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM HAW MEDTRONIC NAVIGATION S7 NA

    Patients

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