BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS

    MDR report key: 3133813 · Received May 23, 2013

    Report

    Report Number
    9610667-2013-00104
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    August 23, 2006
    Report Date
    March 26, 2013
    Manufacturer
    TORNIER SAS
    Product Code
    KWS
    PMA / PMN Number
    K952928
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, BROACH FRACTURED IN CANAL. LEFT BROACH IN PLACE DISTAL TO STEM, SURGICAL FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229208 AEQUALIS NONE KWS TORNIER SAS DWB064

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention