BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAJECTORY GUIDE KIT, BIOPSY, INTERNAL

    MDR report key: 2050785 · Received March 31, 2011

    Report

    Report Number
    1723170-2011-00684
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IS IN-PROGRESS AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL PROCEDURE, THREE SCREWS, WHICH ATTACH THE INTERNAL BASE TO THE SKULL, SHEARED OFF. THEY OPENED THE EXTERNAL TRAJECTORY GUIDE KIT TO GET THE SCREWS OUT. THE SURGEON WAS ABLE TO ATTACH THE BASE TO SUCCESSFULLY PERFORM THE BIOPSY. THE SURGEON WAS ABLE TO REMOVE ALL PIECES OF THE BROKEN SCREWS WITH A DRILL. THE SURGERY WAS COMPLETED WITH THE USE OF THE STEALTHSTATION TREON GUIDANCE SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention