BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, SOLERA STANDARD DRIVER

    MDR report key: 2012251 · Received February 2, 2011

    Report

    Report Number
    1723170-2011-00074
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    MEDTRONIC NAVIGATION , INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. THE DEVICE MANUFACTURE DATE WAS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A SOLERA DRIVER INSERTION SCREW ATTACHED TO THE TRACKER THAT WAS NOT FLUSH. THIS ISSUE ALLOWED "SOME PLAY" ON THE DEVICE THAT LED TO THE PROJECTION BEING "OFF." THE SURGEON OPTED TO CONTINUE THE USE OF THE NAVIGATION SYSTEM TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, SOLERA STANDARD DRIVER STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION , INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK