BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 1924748 · Received December 9, 2010

    Report

    Report Number
    1723170-2010-00166
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATIONS WERE MADE OF MEDTRONIC NAVIGATION'S DEVICE CAUSING OR CONTRIBUTING TO THE PT EVENT. PER THE REPORTED EVENT, THE SURGEON CONFIRMED THAT THE INACCURACY WAS DUE TO HUMAN ERROR. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT A SURGEON CONFIRMED THERE WAS AN INACCURACY WITH A SCREW PLACEMENT BUT REPORTED IT TO BE HUMAN ERROR. THE SURGEON PLACED SIX SCREWS, THE FIRST SCREW WAS OFF, THE OTHER 5 WERE ACCURATE. THE SURGEON RESEATED THE SCREW AND VERIFIED THAT THE PLACEMENT WAS ACCURATE. THERE WAS NO NEGATIVE IMPACT TO THE PT. MEDTRONIC NAVIGATION IS FILING THE MDR TO ENSURE VISIBILITY TO PT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION S7 SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM STEREOTAXIC SYSTEM (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention