BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4972896 · Received August 3, 2015

    Report

    Report Number
    3008788191-2015-00061
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    April 10, 2014
    Report Date
    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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    ONLY TWO CONNECTORS OF THE TIGERPAW SYSTEM II DEVICE WITH 9 CONNECTORS WERE ENGAGED. THE SECOND TIGERPAW SYSTEM II DEVICE WITH 7 CONNECTORS WAS SUCCESSFULLY USED TO COMPLETE PROCEDURE. NO KNOWN PT EFFECT. NO BLOOD LOST REFERRED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505708 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ09 0910M

    Patients

    Seq Age Sex Outcome Treatment
    1