BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS HUMERAL PLATE 90MM

    MDR report key: 2921704 · Received January 15, 2013

    Report

    Report Number
    9610667-2012-00023
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 18, 2012
    Manufacturer
    TORNIER INC.
    Product Code
    KTT
    PMA / PMN Number
    K063551
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PLATE BENT POST-OPERATIVELY IN PT. IMPLANTED ABOUT 2 WEEKS BEFORE. REVISION SURGERY ON (B)(6) 2012 TO REPLACE WITH A LINGER PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22226 AEQUALIS HUMERAL PLATE 90MM HUMERAL PLATE KTT TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention