BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREADED GUIDEWIRE 1.6MM X 500MM

    MDR report key: 1133023 · Received August 22, 2008

    Report

    Report Number
    3005977257-2008-00002
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 22, 2008
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    HXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE TRACKING RECORDS INDICATE THE LOT UTILIZED IN THIS PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD SHOWS DEVICES MEET SPECIFICATIONS. PRELIMINARY INVESTIGATION INTO ROOT CAUSE SUGGESTS THAT PHYSICIAN USE OF DEVICE A SIGNIFICANT CONTRIBUTING FACTOR. INVESTIGATION INTO THIS INCIDENT IS PART OF A BROADER ONGOING INVESTIGATION TO ASSESS PRODUCT PERFORMANCE.

    Description of Event or Problem · 1

    COMPANY REP WAS PRESENT AND REPORTED THAT DURING FACET FUSION AT L3, A GUIDEWIRE WAS SEVERED WHILE PILOTING THE IMPLANT SITE. IT WAS REPORTED THAT THE GUIDEWIRE WAS MISALIGNED AT THE TIME THE FAILURE OCCURED. THE SURGEON DETERMINED NO INTERVENTION WAS REQUIRED AND THE SEVERED PORTION REMAINED IN THE VERTEBRAE. GUIDEWIRE WAS REPLACED AND PROCEDURE COMPLETED. SURGERY TIME WAS EXTENDED BY APPROXIMATELY 5 MINUTES. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THREADED GUIDEWIRE 1.6MM X 500MM HXI SPINEFRONTIER, INC. SI00060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other