BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAYPOINT IMPLANT KIT

    MDR report key: 10424725 · Received August 19, 2020

    Report

    Report Number
    3002250546-2020-00003
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    August 3, 2020
    Report Date
    August 17, 2020
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K092192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS IN SURGERY AND DISCOVERED THAT ONE OF THE WAYPOINT ANCHOR SCREW SITES WAS INFECTED AND PURULENT. IT WAS THE ANTERIOR-RIGHT ANCHOR. THE BURR HOLE HAD NOT YET BEEN DRILLED, SO ONLY THE FIDUCIAL SITE SKIN INCISIONS HAD BEEN MADE. PHYSICIAN WAS GOING TO REMOVE THE ANCHOR AND POSTPONE THE DBS IMPLANTATION TO ANOTHER DATE. PHYSICIAN PLANNED TO RE-IMPLANT NEW FIDUCIALS AND REDESIGN THE PLATFORM FOR THE RESCHEDULED CASE. THERE WAS NO INDICATION OF LARGER HARM TO THE PATIENT, AND PHYSICIAN INTENDS TO RESCHEDULE TO IMPLANT THE SAME WAY SOON. THERE WAS NO INDICATION OF ANY FAILURE OR DEFECT OF THE ANCHOR SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892442 WAYPOINT IMPLANT KIT WAYPOINT STEREOTACTIC SYSTEM HAW FHC, INC. 66-WP-IKS 299002

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization