BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 5000460 · Received August 4, 2015

    Report

    Report Number
    3008788191-2015-00094
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    August 27, 2014
    Report Date
    August 26, 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
    WI, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    FIVE OUT OF NINE CONNECTORS OF THE TIGERPAW SYSTEM II DEVICE WERE NOT ENGAGED. A PLEGETED 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
    510534 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ09 1201M

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR