BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL

    MDR report key: 2000658 · Received February 16, 2011

    Report

    Report Number
    1723170-2011-00124
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    February 12, 2010
    Report Date
    February 12, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT DEMOGRAPHICS WERE UNK. DEVICE MANUFACTURE DATE WAS UNK AS NO LOT NUMBER WAS PROVIDED FOR THE DEVICE. THE DEVICE MALFUNCTION WAS CONFIRMED AND DIRECTLY RELATED TO THE REPORTED EVENT. EVAL OF THE RETURNED SCREW FOUND THAT THE DAMAGE WAS CONSISTENT WITH USER HANDLING. A REPLACEMENT PART WAS SENT TO THE SITE AND THE ISSUE WAS RESOLVED. THE PT WAS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A MEDTRONIC REP CALLED IN TO REPORT THAT A SCREW FROM THE EXTERNAL PASSIVE BIOPSY KIT BROKE OFF IN THE PT'S SKULL. THE SURGEON WAS ABLE TO GET ALL OF THE SCREWS OUT EXCEPT FOR THE VERY TIP OF ONE. THE PT HAS RECOVERED AND WAS REPORTEDLY DOING FINE.

    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 Other