BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.6X12MM VRBL SCR TRINICA

    MDR report key: 3971155 · Received July 8, 2014

    Report

    Report Number
    2184052-2014-00110
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS: 2184052-2014-00109. IT WAS REPORTED THE SCREWS PULLED OUT POST-OPERATIVELY. DURING THE INDEX SURGERY C4-T2 WERE TREATED WITH A 3 LEVEL AND 2 LEVEL PLATE FOR SPONDYLOTIC MYELOPATHY. ALL THE LOCKING CAPS ON THE PLATE WERE NOTED TO BE LOCKED WITHOUT ANY TROUBLE DURING THE FIRST SURGERY. APPROXIMATELY ONE MONTH POST-OPERATIVELY, IT WAS FOUND THAT THE SCREWS C7 PULLED OUT AND THE PATIENT WAS EXPERIENCING PAIN AND SCRATCHING DURING SWALLOWING. IT IS NOTED THE PATIENT ADMITTED TO NOT USING THE COLLAR AS INSTRUCTED POST-OPERATIVELY. THE PATIENT WAS REVISED WITH NEW HARDWARE AND IS REPORTED TO BE RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398491 4.6X12MM VRBL SCR TRINICA 4.6X12MM VRBL SCR TRINICA KWQ ZIMMER SPINE, INC. 07.010118.001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR