BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTARGETING PLATFORM

    MDR report key: 2497903 · Received March 15, 2012

    Report

    Report Number
    3005677147-2012-00001
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 23, 2012
    Manufacturer
    FHC INC.
    Product Code
    HAW
    PMA / PMN Number
    K092192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVALUATION OF THE DEVICE WAS POSSIBLE. THE SURGEON DECIDED THAT SHE WILL PERFORM THE SURGERY WITH A FRAME HENCEFORTH. FHC REPRESENTATIVE WILL ASSIST THE SURGEON WITH ALL THE FUTURE DBS NEEDS. INCIDENT WAS A RESULT OF USER BEING UNEASY WITH THE SYSTEM. FHC IS LOOKING AT MAKING FURTHER IMPROVEMENTS TO THE PLATFORM SYSTEM WHICH WILL MAKE THE USER MORE CONFIDENT ABOUT THE SYSTEM. THERE IS NO INDICATION THAT ANY FHC COMPONENTS WERE AT FAULT AT THIS INCIDENT. THE MP-KIT-02 IS MADE UP OF 2 KITS. MP-KIT-02-01 (SURGICAL KIT) AND MP-KIT-02-02 (MT BILATERAL PLATFORM). THE LOT NUMBER OF MP-KIT-02-01 IS 127262 AND SERIAL NUMBER OF MP-KIT-02-02 IS (B)(4).

    Description of Event or Problem · 1

    FHC SALES REPRESENTATIVE REPORTED THAT THE SURGEON WAS UNCOMFORTABLE WITH FINDING THE FIDUCIAL AND ALSO THE CORRECT ANGLE TO THREAD THE STANDOFF ON THE ANCHOR. THE SURGEON DECIDED TO ABORT THE CASE SINCE ONE FIDUCIAL AND STANDOFF HAD COME OUT COMPLETELY AND ONE OF THE POSTERIOR STANDOFFS WERE TOO LOSE WHICH COULD AFFECT THE ACCURACY OF THE DEVICE. THE SURGERY WAS ABORTED BEFORE THE BURR HOLE WAS OPENED HENCE POSING LOW RISK TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING PLATFORM MT PLATFORM HAW FHC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK