BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDQ

    MDR report key: 3133762 · Received May 23, 2013

    Report

    Report Number
    3004983210-2013-00008
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    September 7, 2011
    Report Date
    March 26, 2013
    Manufacturer
    TORNIER INC
    Product Code
    KWT
    PMA / PMN Number
    K071147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    INTRA OP, HUMERAL FRACTURE, GT FRACTURE/SUTURE REPAIR, SURGICAL FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228962 ASCENDQ NONE KWT TORNIER INC 503308A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention