BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL

    MDR report key: 2041223 · Received March 30, 2011

    Report

    Report Number
    1723170-2011-00719
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    June 1, 2010
    Report Date
    June 1, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO AVAILABLE FROM THE SITE. THE DEVICE MANUFACTURE DATE WAS UNK AS NO LOT NUMBER WAS PROVIDED. THE DEVICE WAS A DISPOSABLE DEVICE AND WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT, IN A CASE IN (B)(6) 2010, THE SCREW COULD NOT BE REMOVED FROM THE PT'S SKULL WITH THE SCREWDRIVER. THE SURGEON HAD TO DRILL THE SCREW OUT, WHICH MADE A SECOND BURR HOLE. THEY HAD TO USE TWO BURR HOLE COVERS, OR A LARGER ONE, TO CLOSE THE HOLES. PT INFO, EXACT DATE OF SURGERY AND LOT/PART NUMBER OF TRAJECTORY GUIDE KIT ARE UNK.

    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 Required Intervention