BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAYPOINT STEREOTACTIC PLATFORM

    MDR report key: 8927503 · Received August 23, 2019

    Report

    Report Number
    3002250546-2019-00006
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    July 24, 2019
    Report Date
    August 23, 2019
    Manufacturer
    FHC, INC,
    Product Code
    HAW
    UDI-DI
    00873263005903
    PMA / PMN Number
    K092192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PLATFORM USED IN THE SURGERY WAS RETURNED AND EVALUATED. THE INVESTIGATION SHOWS THAT NO ISSUES WERE FOUND DURING RECEIVING, PROCESSING, MANUFACTURING AND QC'ING OF THE ORIGINAL PLATFORM. THE RETURNED PLATFORM WAS INSPECTED AND FOUND TO HAVE NON-CONFORMING MEASUREMENTS THAT ARE WELL OVER THE SPECIFIED TOLERANCES. THIS IS INDICATIVE THAT THE GEOMETRY OF THE PLATFORM WAS ALTERED AFTER LEAVING FHC. THE FOLLOW-UP CASE WAS SUCCESSFUL. SINCE THE SECOND PLATFORM WAS PROCESSED, MANUFACTURED AND QC'D JUST AS THE ORIGINAL, THIS LENDS TO THE CONCLUSION THAT THE PROBLEM WITH THE FIRST PLATFORM HAPPENED OUTSIDE OF FHC CONTROL. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    PHYSICIAN HAD DIFFICULTY ATTACHING THE STARFIX PLATFORM TO THE IMPLANTED FIDUCIALS AT THE START OF THE CASE. HE CHECKED MULTIPLE TIMES THE PEEK STANDOFFS FROM THE SKS KITS AND WAS STILL HAVING DIFFICULTY ATTACHING THE FINAL POSTERIOR LEFT FOOT THE STANDOFF. IT SHOWED A 3MM POSTERIOR SHIFT THAT PHYSICIAN DID NOT FEEL COMFORTABLE PROCEEDING WITH THE SURGERY WITH 3 LEGS WITHOUT KNOWING WHY THE 4TH LEG WAS SHIFTED SO MUCH. THE SURGERY WAS CANCELLED AND THE IMPACT TO THE PATIENT WAS OPENING THE FIDUCIAL SITES AND CLOSING AGAIN AND HAVING THE PATIENT GET ANOTHER CT TO DOUBLE CHECK EVERYTHING. THE CASE CONCLUDED SUCCESSFULLY WITH THE USE OF THE PLATFORM CREATED FROM THE 2ND SET OF CT SCANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722120 WAYPOINT STEREOTACTIC PLATFORM WAYPOINT STEREOTACTIC SYSTEM HAW FHC, INC, MP-KIT-P-BI 00873263005903

    Patients

    Seq Age Sex Outcome Treatment
    1