BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREADED GUIDEWIRE 1.6MM X 500MM

    MDR report key: 1155244 · Received September 8, 2008

    Report

    Report Number
    3005977257-2008-00003
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 7, 2008
    Report Date
    September 8, 2008
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE TRACKING RECORDS INDICATE THE POSSIBLE LOT NUMBERS OF GUIDEWIRES USED IN THIS PROCEDURE. A REVIEW OF THOSE LOT HISTORY RECORDS SHOWS THE DEVICES MEET SPECIFICATION. PRELIMINARY INVESTIGATION INTO ROOT CAUSE INDICATE 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

    A GUIDEWIRE WAS SEVERED AT THE THREADED PORTION OF THE GUIDEWIRE WHILE PILOTING THE IMPLANT SITE. IT WAS REPORTED THAT THE GUIDEWIRE TRAJECTORY WAS MANEUVERED WHILE DRILLING AND AT THE TIME THE GUIDEWIRE BROKE. THE SURGEON DETERMINED NO INTERVENTION WAS REQUIRED AND THE SEVERED PORTION REMAINED IN THE VERTEBRA. GUIDEWIRE WAS REPLACED AND PROCEDURE COMPLETED. SURGERY TIME WAS EXTENDED BY APPROX. 5 MINUTES. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THREADED GUIDEWIRE 1.6MM X 500MM LXH SPINEFRONTIER, INC. SI00060 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other