BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4976091 · Received August 4, 2015

    Report

    Report Number
    3008788191-2015-00057
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    February 4, 2014
    Report Date
    February 7, 2014
    Manufacturer
    LAAX INC
    Product Code
    GDW
    Removal / Correction Number
    Z-1461-2015/Z1462-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    PINS WERE NOT CONNECTED DURING TIGERPAW SYSTEM II DEVICE USE. THE SECOND TIGERPAW SYSTEM II DEICE WAS SUCCESSFULLY USED TO COMPLETE PROCEDURE. NO KNOWN PATIENT EFFECT. NO BLOOD LOST REFERRED TO THIS EVENT. NO ADD'L MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510968 TIGERPAW SYSTEM II STAPLE, IMP;LANTABLE GDW LAAX INC TP15AJ09 0898M

    Patients

    Seq Age Sex Outcome Treatment
    1