BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINE TRACKER

    MDR report key: 2974615 · Received January 17, 2013

    Report

    Report Number
    3007582679-2013-90002
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 21, 2012
    Manufacturer
    STRYKER NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K003111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS EVALUATED. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE, THE SPINE TRACKER CAUSED A 30 TO 40 MINUTE PROCEDURE DELAY BECAUSE IT WOULD NOT INITIALIZE. THE PROCEDURE WAS COMPLETED BY TRADITIONAL METHODS WITHOUT INCIDENT. NO ADVERSE EVENT WAS ASSOCIATES WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27288 SPINE TRACKER HAW STRYKER NAVIGATION 10276

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK