BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAYPOINT PLANNER

    MDR report key: 6897451 · Received September 27, 2017

    Report

    Report Number
    3002250546-2017-00005
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 27, 2017
    Manufacturer
    FHC, INC
    Product Code
    HAW
    UDI-DI
    00873263004371
    PMA / PMN Number
    K092192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL PLANNING FILE WAS EVALUATED BY THE FHC, INC. SOME AREAS OF FLOODING ARE EVIDENT IN THE CT SCAN. MERGING ISSUES ARE NOTICED AROUND THE SKULL (PREDOMINANTLY THE OUTER AND INNER EDGES) INDICATIVE OF A SKEW IN ONE DIRECTION. THE AMOUNT OF MISALIGNMENT IS DIFFICULT TO JUDGE QUANTITATIVELY. BASED ON SCANS AND FACTS PROVIDED BY CUSTOMER DEVELOPMENT TECHNICIANS FOR THIS CASE, IT IS DETERMINED THAT WAYPOINT PLANNER FUNCTIONED AS IT WAS ORIGINALLY DESIGNED TO. THE SOFTWARE DID NOT EXHIBIT A FAILURE OR BUG AS A RESULT OF LOADING AND MERGING THE DICOM IMAGES. THE INABILITY OF PLANNER TO PRODUCE A MERGE THAT MET THE SATISFACTION OF THE USER CAN BE ATTRIBUTED TO POOR IMAGE QUALITY DUE TO SCANNERS AT THE FACILITY. THE SURGERY WAS RE-PLANNED USING WAYPOINT NAVIGATOR AND WAS COMPLETED SUCCESSFULLY WITH NO MISALIGNMENT.

    Description of Event or Problem · 1

    SURGEON REPORTED TO FHC'S TECHNICAL SUPPORTIVE REPRESENTATIVE REGARDING IMAGE REGISTRATION IN WAYPOINT PLANNER (66-WP-PL). THE PATIENT WAS PREVIOUSLY INSTALLED WITH BONE ANCHORS AND HAD UNDERGONE CT AND MRI SCAN. THE SURGEON DID NOT LIKE THE IMAGE REGISTRATION WITH WAYPOINT PLANNER (66-WP-PL) AND DECIDED TO USE A FRAME FOR THE PATIENT. THREE SCANS WERE AVAILABLE FOR REVIEW; CT WITH ANCHORS, MRI AND CT WITH ANCHORS AND FRAME. THE CT WITH ANCHORS AND CT WITH ANCHORS AND FRAME MERGED VERY WELL. THE CT TO MRI SHOWED AC AND PC TO BE MORE THAN A MILLIMETER OFF. AS A RESULT OF THIS, SURGEON DECIDED TO RESCHEDULE THE SURGERY. THERE WAS NO EVIDENCE THAT THE PATIENT WAS HARMED IN ANYWAY BY RESCHEDULING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677704 WAYPOINT PLANNER WAYPOINT PLANNER HAW FHC, INC 66-WP-PL 00873263004371

    Patients

    Seq Age Sex Outcome Treatment
    1 Other