BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINICA SCREW SELF-DRILLING VARIABLE 4.2X14

    MDR report key: 3912434 · Received May 14, 2014

    Report

    Report Number
    2184052-2014-00084
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS: 2184052-2014-00085. IT WAS REPORTED THE SCREWS BROKE POST-OPERATIVELY. THE ORIGINAL SURGERY (TIME NOT REPORTED) TREATED C6-C7 WITH A ONE LEVEL PLATE. REVISION SURGERY WAS PERFORMED WITH EXTENT THE CONSTRUCT AND THE PATIENT WAS FUSED AT THE TREATED LEVELS. AT THE TIME OF REVISION IT WAS NOTED ON X-RAY THE 14MM SCREWS AT C7 WERE BROKEN. THE SCREWS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288332 TRINICA SCREW SELF-DRILLING VARIABLE 4.2X14 TRINICA SCREW SELF-DRILLING VARIABLE 4.2X14 KWQ ZIMMER SPINE, INC. 07.00812.005 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1