BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4988440 · Received August 5, 2015

    Report

    Report Number
    3008788191-2015-00075
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    April 16, 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
    AK, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    2 (TWO) CONNECTORS OUT OF 9 OF THE TIGERPAW SYSTEM II DEVICE WERE NOT ENGAGED. SUTURES WERE USED TO COMPLETE PROCEDURE. NO KNOWN BLOOD LOST OR INJURY REFERRED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517459 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX, INC. TP15AJ09 0910M

    Patients

    Seq Age Sex Outcome Treatment
    1