BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEPORT

    MDR report key: 2045688 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00066
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Report Date
    February 10, 2009
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: USER ERROR. EXPLANATION: PHYSICAL INVESTIGATION OF THE INSTRUMENT REVEALED THAT THE TELEPORT OUTER HANDLE WAS BROKEN AT THE FEATURE WHICH LOCKS WITH THE INTERMEDIATE HANDLE. THIS OCCURS WHEN THE USER DOES NOT RELEASE THE "PULL 2" BUTTON WHILE ACTUATING THE OUTER HANDLE OFF THE INTERMEDIATE HANDLE. THE REPORT INDICATES THE SURGEON USED A MALLET DURING THE CASE. THE SALES REP SHOULD BE REMINDED THAT A MALLET OR HAMMER SHOULD NEVER BE USED FOR INSERTION OF THE TELEPORT. 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: RETURNED OUTER HANDLE VISUALLY INSPECTED. HANDLE WAS BROKEN AT THE FEATURE WHICH LOCKS WITH THE INTERMEDIATE HANDLE.

    Description of Event or Problem · 1

    PLASTIC LOCK BROKEN. THE SURGEON UTILIZED A MALLET DURING THE CASE. THERE WERE NO COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEPORT GAD INTERVENTIONAL SPINE, INC. 6086-00 090707-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention