BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTARGETING DRIVE SYSTEM

    MDR report key: 1012405 · Received March 14, 2008

    Report

    Report Number
    3005677147-2008-00002
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 14, 2008
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K011775
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FHC RECEIVED THE PLANNING FILES FROM THE PHYSICIAN AS WELL AS THE MICROTARGETING PLATFORM TO INVESTIGATE THE CAUSE OF THE ERROR. REVIEW OF THE PLANNING FILES SHOWED THAT THE SURGEON HAD USED A NON-VALIDATED VERSION OF THE PLANNING SOFTWARE FOR CREATION OF THE PLATFORM. HOWEVER, THIS WAS NOT THE CAUSE OF THE POOR FIT OF THE PLATFORM AND IT SHOULD BE NOTED THAT VANDERBILT IS THE PRIMARY DEVELOPER OF THE VALIDATED SOFTWARE VERSION CURRENTLY USED AND THEY OPERATE UNDER AN IRB FOR DEVELOPMENT OF OTHER PLANNING SOFTWARES. THIS PLATFORM WAS BUILT BY HARVEST TECHNOLOGIES, AN INSPECTED AND VALIDATED MANUFACTURING PARTNER FOR FHC, AND DIRECT-SHIPPED TO VANDERBILT. THE QUALIFIED PARTNER INSPECTED THE PLATFORM TO FHC QC STANDARDS AND FOUND THAT IT MET ALL QUALITY SPECIFICATIONS. FHC CREATED THE REPLACEMENT PLATFORM ON ITS OWN EQUIPMENT, FOUND IT TO PASS QC INSPECTION AND SHIPPED IT TO VANDERBILT FOR THE FOLLOW-UP SURGERY. THIS PLATFORM PERFORMED CORRECTLY AND ACCORDING TO SPECS. FURTHER REVIEW OF THE MATTER FOUND NO PROBLEMS WITH THE PLANNING, SOFTWARE OR PLATFORM FILE THAT COULD HAVE CAUSED THE ERROR. THERE WAS NO MOVEMENT OF THE ANCHORS IN THE PT AND THE REGISTRATION OF THE ANCHORS ON ONE LEG OF THE PLATFORM, THE LEG THAT DIDN'T FIT CORRECTLY ONTO THE ANCHOR. THE CONCLUSION IS THAT SOME PHYSICAL CAUSE, EITHER SOME EXTERNAL FORCE WHILE HOT DURING STERILIZATION, OR STRESS RELIEF DUE TO THE NOTICEABLE LAYERING, MOVED THE LEG DURING STERILIZATION AS THE QC INSPECTION DATA PRIOR TO THE SURGERY DID NOT SHOW THIS ANOMALY.

    Description of Event or Problem · 1

    NEUROSURGEON REPORTED A CASE WHERE ONE OF FOUR FEET OF A BILATERAL MICROTARGETING PLATFORM DID NOT FIT THE ANCHOR WHEN HE WENT TO APPLY IT TO THE PT. HE SAID THE FOOT WAS OFF APPROXIMATELY 6MM. THE OTHER THREE FEET WERE CORRECT, BUT THE SURGERY WAS CANCELLED DUE TO UNCERTAINTY. PT HAD UNDERGONE SURGICAL PREPARATION INCLUDING INCISIONS MADE ABOVE THE BONE ANCHORS. AS A RESULT, THE SURGERY WAS RESCHEDULED AND A NEW MICROTARGETING PLATFORM WAS CREATED. THIS PLATFORM FIT THE ANCHORS CORRECTLY, AND THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING DRIVE SYSTEM STEREOTACTIC POSITIONER HAW FHC, INC. MP-KIT-11

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other