BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1033729 · Received April 9, 2008

    Report

    Report Number
    1033729
    Event Type
    Malfunction
    Date Received
    April 9, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 8, 2008
    Manufacturer
    TORNIER
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A SHOULDER OPERATION. WHILE THE PATIENT WAS IN PACU THE SURGEON ORDERED AN X-RAY. THE SURGEON STATED THE POSITION OF THE IMPLANTS REQUIRED A REVISION. TWO OF THE IMPLANTED ITEMS WERE REMOVED AND REPLACED. THIS REPORT PERTAINS TO THE GLENOID SPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * IMPLANT, SHOULDER, ORTHOPEDIC HSD TORNIER * C 4012AG 4

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR