BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINICA THREADED FIXATION PIN

    MDR report key: 1402501 · Received June 15, 2009

    Report

    Report Number
    2184052-2009-00019
    Event Type
    Injury
    Date Received
    June 15, 2009
    Date of Event
    May 15, 2009
    Report Date
    May 15, 2009
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    JDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHEN THE SURGEON REMOVED THE TEMPORARY FIXATION PIN, THE PIN BROKE OFF BELOW BONE LEVEL. THE SURGEON REMOVED THE PLATE AND 4 SCREWS, DRILLED OUT THE BROKEN PIECE AND REPLACED THE PLATE USING LARGER SCREWS. AN ADDITIONAL 15 MINUTES WAS ADDED TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINICA THREADED FIXATION PIN FIXATION PIN JDW ZIMMER SPINE, INC. 07.00656.002 60764301

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention