BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEPORT

    MDR report key: 2045657 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00008
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    April 4, 2007
    Report Date
    May 14, 2007
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE WAS THE MATERIALS WERE NOT ABLE TO SURVIVE THE FORCE THE SURGEONS APPLIED. IN ORDER TO IMPROVE THE DURABILITY OF THE DEVICE, SOME COMPONENTS WERE CHANGED FROM PLASTIC TO ALUMINUM. INITIALLY WHEN THIS EVENT WAS REPORTED, IT WAS DETERMINED THE EVENT WAS NOT REPORTABLE. ON A SUBSEQUENT RE-REVIEW, IT WAS DETERMINED THAT THIS EVENT SHOULD BE REPORTED. THE DEVICE WAS NOT RE-EVALUATED BECAUSE THE IDENTIFIED EVENTS HAD ALREADY BEEN REPORTED IN REPORTS 2032499-2011-0006 AND 2032499-2011-00007.

    Description of Event or Problem · 1

    DISPOSABLE TELEPORT BROKE AT THE FUNCTION OF THE HANDLE AND SHEATH OF THE LAST PORTION OF THE TELEPORT (THIRD DIALATOR). THIS OCCURRED WHILE ADVANCING THE LAST SHEATH OF THE TELEPORT. SURGEON WAS STILL ABLE TO USE PORTAL ACCESS. NO HARM OR COMPLICATIONS TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEPORT FZX INTERVENTIONAL SPINE, INC. 9044 112706A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention