BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREADED GUIDEWIRE 1.6MM X 500MM

    MDR report key: 1155307 · Received September 9, 2008

    Report

    Report Number
    3005977257-2008-00004
    Event Type
    Injury
    Date Received
    September 9, 2008
    Date of Event
    August 7, 2008
    Report Date
    September 9, 2008
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THE DEVICES MEET SPECIFICATION. ADDITIONAL INFORMATION GATHERED DURING INVESTIGATION FOUND THAT THE GUIDEWIRE HAD BEEN INSERTED (DRILLED) MULTIPLE TIMES. INVESTIGATION INTO THIS INCIDENT IS PART OF A BROADER ONGOING INVESTIGATION TO ASSESS PRODUCT PERFORMANCE. THE BROKEN GUIDEWIRE FROM THIS EVENT WAS RECEIVED ON 8/13/08 AND SUBSEQUENTLY EVALUATED BY THE ENGINEERING AND QUALITY TEAMS. IT WAS DETERMINED THROUGH VISUAL EXAMINATION THAT THE GUIDEWIRE HAD BEEN BENT DURING DRILLING, CONCLUDED BY THE BEND AND TWIST OBSERVED ON THE DEVICE. ROTATION AND TORQUE APPLIED TO THE SPINNING (WHILE DRILLING) GUIDEWIRE WAS SUFFICIENT ENOUGH TO CAUSE THE GUIDEWIRE TO SHEAR WHERE THE THREADED SECTION MEETS THE NON-THREADED SECTION OF THE GUIDEWIRE. INSTRUCTIONS FOR USE REQUIRE THAT DEVICE ALIGNMENT BE MAINTAINED TO PREVENT DAMAGE TO INSTRUMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 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 REMOVED AND FIXATION 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 LXH SPINEFRONTIER, INC. SI00060 94703

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other