BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4951781 · Received July 28, 2015

    Report

    Report Number
    3008788191-2015-00022
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    July 23, 2012
    Report Date
    July 27, 2012
    Manufacturer
    LAAX, INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Removal / Correction Number
    Z-1461-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    FASTENER OF THE TIGERPAW SYSTEM II WOULDN'T FULLY DEPLOY. END BARBS WOULDN'T ATTACH. THERE WAS NOT KNOWN PATIENT EFFECT. IT'S ASSUMED THAT A MEDICAL INTERVENTION (SUTURE) WAS USED TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491737 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX, INC TP15AJ07 0633M

    Patients

    Seq Age Sex Outcome Treatment
    1