BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL

    MDR report key: 1924741 · Received December 9, 2010

    Report

    Report Number
    1723170-2010-00158
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 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 WEIGHT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. THE SINGLE-USE DEVICE WAS DISCARDED AT THE HOSP. NO LOT NUMBER OR SERIAL NUMBER WAS AVAILABLE. THE SINGLE-USE DEVICE WAS DISPOSED OF AT THE HOSP. AN EVAL OF THE DEVICE WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE SCREW OF THE BASE USED IN A BIOPSY PROCEDURE STRIPPED AND WAS UNABLE TO BE REMOVED. WHEN THE SURGEON WAS ATTEMPTING TO REMOVE THE SCREW, IT BROKE OFF AND REMAINED IMPLANTED IN THE PT. THE SURGEON CLOSED UP AND THE PT WAS X-RAYED ON THE OPERATING ROOM TABLE, REVEALING THE SCREW IN THE EPIDURAL BETWEEN THE DURA AND THE BONE. THE SURGEON REOPENED THE PT AND REMOVED THE SCREW. THE PT WAS REPORTED AS DOING FINE, WITH NO IMPACT ON PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL STEREOTAXIC SYSTEM (HAW) HAW MEDTRONIC NAVIGATION, INC. 00613994157119 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention