BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEPORT

    MDR report key: 2045710 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00024
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    June 1, 2009
    Report Date
    June 4, 2009
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE AND CORRECTIVE ACTION - TELEPORTS WOULD NOT DISLODGE DUE TO EXCESS ADHESIVE APPLIED TO COMPONENTS - PROCEDURES AND MANUFACTURING AIDS WERE REVISED TO CONTROL APPLICATION OF ADHESIVE. INITIALLY, IT WAS DETERMINED THE EVENT WAS NOT REPORTABLE. ON A SUBSEQUENT RE-REVIEW, IT WAS DETERMINED THIS EVENT SHOULD HAVE BEEN REPORTED. DEVICE EVALUATION: TELEPORTS THAT WERE RECEIVED WERE VISUALLY INSPECTED AND ENGAGED AND DISENGAGED.

    Description of Event or Problem · 1

    THREE TELEPORTS WERE OPENED FOR THE CASE. TELEPORT 1 - THE TELEPORT WAS OPENED AND POSITION OVER K WIRE IN PATIENT. FIRST TAB WAS PULLED. THE 2ND DILATOR ADVANCE. WHEN THE 2ND PULL TAB WAS PULLED, THE OUTER DILATOR WOULD NOT RELEASE AND ADVANCE FROM THE HANDLE. IT WAS REMOVED FROM THE PATIENT. BOTH THE TECHNICIAN AND PHYSICIAN ATTEMPTED TO DISLODGE, BUT WITHOUT SUCCESS. TELEPORT 2 - THE SECOND TELEPORT WAS USED FOR TWO OF THE FOUR SCREWS TO BE IMPLANTED. WHEN THE SURGEON ATTEMPTED TO ADVANCE, THE 2ND DILATOR ADVANCED WITHOUT PULLING THE 1ST PULL TAB. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL PULLING AND TURNING THE PULL TAB, OR TUGGING ON THE DISTAL TIP DID NOT LOCK IN THE DILATOR. THE SURGEON, ABANDONED THE 2ND TELEPORT. TELEPORT 3 - A THIRD TELEPORT WAS OPENED. THE TELEPORT WAS CHECKED. THE FIRST PULL TAB WOULD NOT LOCK. ON THE FOURTH ATTEMPT, THE FIRST DILATOR LOCKED IN PLACE AND WAS USED SUCCESSFULLY. FOLLOW UP WITH THE PHYSICIAN INDICATED THERE WERE NO PATIENT ISSUES WITH THE USE OF THESE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEPORT FZX INTERVENTIONAL SPINE, INC. 9044-00 020609-B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention