BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FHC WAYPOINT STEREOTACTIC SYSTEM

    MDR report key: 10756025 · Received October 29, 2020

    Report

    Report Number
    3002250546-2020-00006
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 27, 2020
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    UDI-DI
    00873263005903
    PMA / PMN Number
    K092192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN INFORMED FHC THAT THERE WAS AN ISSUE WITH A STARFIX CASE. PHYSICIAN REPORTS THAT A PLATFORM HEIGHT OF 130 WAS CHOSEN FOR THE PLAN FOR THIS BILATERAL PLATFORM FOR PATIENT. IN THE CASE PHYSICIAN OBSERVED A VALUE OF T=30 ON THE PLATFORM EMBOSSING. BEING NEW TO STARFIX, SHE FOLLOWED THIS LABEL AND IMPLANTED THE LEAD AT 30 WITHOUT QUESTIONING IT. IN POST-OPERATIVE SCANS, IT WAS OBSERVED THAT THE LEAD IS 10 MM SHORT OF HER TARGET. THE PATIENT IMPACT IS THAT HE/SHE WILL REQUIRE A REVISION WHICH BICK PLANS TO DO USING ROSA. PHYSICIAN INFORMED FHC THAT THEY DECIDED TO BRING THE PATIENT BACK IN FOR A REVISION ON10/1 WITH THE SAME PLATFORM. THEY RE-PROCESSED THE PLATFORM AND REATTACHED WITHOUT ISSUE. PATIENT DID VERY WELL DURING THE REVISION SURGERY AND IN POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221994 FHC WAYPOINT STEREOTACTIC SYSTEM STEREOTACTIC INSTRUMENT HAW FHC, INC. MP-KIT-P-BI-00590 00873263005903

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization