BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZX TREPEZIUM IMPLANT

    MDR report key: 2542595 · Received April 13, 2012

    Report

    Report Number
    3007289093-2012-00002
    Event Type
    Injury
    Date Received
    April 13, 2012
    Date of Event
    January 24, 2011
    Report Date
    April 13, 2012
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    KYI
    PMA / PMN Number
    K092548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON PERFORMED AND REMOVED THE TRAPEZIUM IMPLANT AND A LRTI PROCEDURE WAS COMPLETED. THE IMPLANT WAS RETURNED FOR EVAL. THIS IS THE FIRST REPORTED EVENT WHERE THE SUTURE HAD FAILED POST-OPERATIVELY.

    Description of Event or Problem · 1

    PT REQUIRED SURGERY TO REMOVE TRAPEZIUM IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZX TREPEZIUM IMPLANT WRIST JOINT CARPAL TREAPEZIUM PROSTHESIS KYI EXTREMITY MEDICAL, LLC. AP4N09A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention