BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL

    MDR report key: 2041240 · Received March 30, 2011

    Report

    Report Number
    1723170-2011-00721
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 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. COMMENT MADE IN A REPORT THAT THIS INCIDENT HAPPENED "SOME TIME IN (B)(6) 2010". THE DEVICE MFR DATE WAS UNK AS NO LOT NUMBER WAS PROVIDED. THE DEVICE WAS 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