BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4988447 · Received August 5, 2015

    Report

    Report Number
    3008788191-2015-00083
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 7, 2014
    Report Date
    July 17, 2014
    Manufacturer
    LAAX, INC.
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Removal / Correction Number
    Z-1461-2015, Z-1462-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    CONNECTORS OF THE TIGERPAW II DEVICE WERE ENGAGED PARTIALLY. A SUTURE WAS USED TO COMPLETE PROCEDURE. THERE WAS NO BLEEDING BASED ON THIS EVENT. THERE WERE NO PATIENT NEGATIVE EFFECTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515898 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX, INC. TP15AJ09 1154M

    Patients

    Seq Age Sex Outcome Treatment
    1