BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATION SYSTEM II

    MDR report key: 2942050 · Received December 27, 2012

    Report

    Report Number
    3007582679-2012-00057
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 4, 2012
    Manufacturer
    STRYKER NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K993239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT WITHOUT AN EVALUATION OF THE DEVICE. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE DEVICE IS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN LOST VISIBILITY OF THE TRACKER AND THE POINTER DURING A CRANIAL PROCEDURE. THE PROCEDURE WAS COMPLETED BY TRADITIONAL METHODS WITHOUT INCIDENT AND WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIGATION SYSTEM II HAW STRYKER NAVIGATION

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK