BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV CD HORIZON SOLERA 4.75MM DRIVER

    MDR report key: 2193619 · Received July 13, 2011

    Report

    Report Number
    1723170-2011-01225
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 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

    DEVICE MANUFACTURE DATE IS UNAVAILABLE AT THIS TIME AS IT IS DEPENDENT ON THE LOT NUMBER. PART REPLACEMENT NEEDED TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT A SOLERA NAVLOCK DRIVER WAS DAMAGED WHILE IN A CASE. THE TIP BROKE OFF THE END OF THE SOLERA STANDARD DRIVER; THE SURGEON CONTINUED USING THE NAVIGATED REDUCTION SOLERA DRIVER TO COMPLETE THE PROCEDURE. THE REDUCTION DRIVER WAS AVAILABLE AND IN THE SURGICAL FIELD WHEN THIS OCCURRED. NO IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAV CD HORIZON SOLERA 4.75MM DRIVER STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR