BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM

    MDR report key: 3106323 · Received April 8, 2013

    Report

    Report Number
    3008788191-2013-00001
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    February 13, 2013
    Report Date
    April 8, 2013
    Manufacturer
    LAAX, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT WAS USER FACILITY REPORT PROVIDED BY FDA ON (B)(6) 2013. ADD'L F/U WITH DISTRIBUTOR AND USER FACILITY ON (B)(6) 2013 CONFIRMED LAAX, INC. DEVICE WAS SUBJECT OF EVENT.

    Description of Event or Problem · 1

    AS DEVICE WAS BEING USED ON THE FIELD, IT FELL APART. THIS CREATED MORE TIME INVOLVED TO DO THIS CASE. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144741 TIGERPAW SYSTEM STAPLE, IMPLANTABLE GDW LAAX, INC. TP15AJ07 0640M

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other