BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, SOLERA STANDARD DRIVER

    MDR report key: 2871777 · Received December 13, 2012

    Report

    Report Number
    1723170-2012-00722
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP OF THE INSTRUMENT IS TWISTED, BUT NOT BROKEN AS REPORTED. A REPLACEMENT PART WAS SHIPPED TO THE SITE (B)(4) 2012.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHEN USING THE POWEREASE THE TORQUE MADE THE TIP OF THE DRIVER BREAK. THEY TOOK OUT THE SCREW AND PUT A NEW ONE IN. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, SOLERA STANDARD DRIVER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120223

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR