BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4976098 · Received August 4, 2015

    Report

    Report Number
    3008788191-2015-00056
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    January 24, 2014
    Report Date
    January 31, 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
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    TWO DISTAL PINS WERE NOT CONNECTED DURING TIGERPAW SYSTEM II DEVICE USE. THIS PORTION OF THE FASTENER MOST LIKELY WAS NOT ON TISSUE. NO KNOWN PATIENT EFFECT. NO BLOOD LOST REFERRED TO THIS EVENT. NO ADDITIONAL MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510599 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ09 0898M

    Patients

    Seq Age Sex Outcome Treatment
    1