BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV CD HORIZON SOLERA 4.75MM DRIVER

    MDR report key: 2220089 · Received August 9, 2011

    Report

    Report Number
    1723170-2011-01273
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 18, 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

    LOT NUMBER NOT AVAILABLE AT TIME OF THIS REPORT. DEVICE MANUFACTURE DATE IS DEPENDENT ON THE LOT NUMBER, AND NOT AVAILABLE AT THIS TIME. RMA ISSUED. REPLACEMENT PART SHIPPED (B)(4) 2011. SUSPECT PART HAS NOT BEEN RETURNED TO THE MFR. SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REP CALLED IN TO REQUEST AN RMA FOR A SOLERA NAVLOCK DRIVER. THE MEDTRONIC REP REPORTED THE CURRENT PART WAS BENT; THE TIP OF THE SOLERA STANDARD DRIVER APPEARS TWISTED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. NO IMPACT ON THE PT OUTCOME WAS 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. S7 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1