BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4972796 · Received August 3, 2015

    Report

    Report Number
    3008788191-2015-00070
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    May 9, 2014
    Report Date
    May 12, 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
    SC, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVAL (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    THE FASTENER WAS NOT RELEASED FROM THE DELIVERY TOOL OF TIGERPAW SYSTEM II. THE SECOND TIGERPAW SYSTEM II WAS SUCCESSFULLY 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
    505106 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ09 1121M

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR