BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL, TRAJECTORY GUIDE KIT (NAVIGUS)

    MDR report key: 2101696 · Received May 11, 2011

    Report

    Report Number
    1723170-2011-00950
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE WAS UNKNOWN AS NO LOT NUMBER WAS PROVIDED. THE DEVICE WAS A DISPOSABLE ITEM AND WAS NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A CRANIAL CASE WITH A PASSIVE BIOPSY NAVIGUS SET, THE SURGEON STRIPPED MULTIPLE SCREWS AND BENT THE SCREWDRIVER THAT REQUIRED HIM TO OPEN A SECOND BOX. THE BIOPSY WAS ABLE TO OBTAIN USABLE TISSUE AND THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERNAL, TRAJECTORY GUIDE KIT (NAVIGUS) STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR