BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRINICA CERVICAL PLATE SYSTEM

    MDR report key: 1364029 · Received January 16, 2009

    Report

    Report Number
    2184052-2009-00003
    Event Type
    Other
    Date Received
    January 16, 2009
    Report Date
    December 18, 2008
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ORIGINAL SURGERY WAS PERFORMED ON (B) (6)2005 TO IMPLANT A TRINICA PLATE AND SCREWS. REVISION SURGERY WAS PERFORMED (B) (6)2006 AFTER ONE OF THE SELF-TAPPING SCREWS ALLEGEDLY BROKE WHILE THE PT WAS STRETCHING DURING A LONG FLIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINICA CERVICAL PLATE SYSTEM SELF-TAPPING VARIABLE SCREW, 14MM KWQ ZIMMER SPINE, INC. 07.00117.002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other