BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL

    MDR report key: 2121879 · Received May 23, 2011

    Report

    Report Number
    1723170-2011-00987
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    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

    PT INFO WAS NOT AVAILABLE FROM THE SITE. DEVICE MFR DATE WAS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. THE DISPOSABLE DEVICE WAS NOT RETURNED TO THE MFR.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT AFTER PLACING THE STRAIGHT BASE IN A BIOPSY PROCEDURE, THEY WERE UNABLE TO GET THEIR TRAJECTORY, SO THE SURGEON HAD TO SWITCH TO THE ANGLED BASE. ALL OF THE SCREWS WERE STRIPPED SO THEY COULDN'T USE THOSE SCREWS FOR THE ANGLED BASE. HE REQUESTED THAT THEY OPEN A NEW KIT TO CONTINUE WITH THE CASE. THERE WAS NO IMPACT TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1