BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRINICA ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 562452 · Received May 20, 2004

    Report

    Report Number
    2184052-2004-00007
    Event Type
    Other
    Date Received
    May 20, 2004
    Date of Event
    April 29, 2004
    Report Date
    May 20, 2004
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    HWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A TRINICA SELECT PLATE IMPLANT, USING FOUR SCREWS, DURING A ONE LEVEL CERVICAL PROCEDURE. X-RAYS TAKEN IN APRIL 2004 INDICATED ONE BROKEN TRINICA 4.2 X 16 MM VARIABLE SCREW. INITIAL SURGERY 2003. REVISION SURGERY 2004. ACCORDING TO REP, X-RAYS TAKEN IN APRIL 2004 AND DISCOVERED A BROKEN SCREW. SINGLE LEVEL CONSTRUCT. ANATOMICAL LOCATION UNK. CONSTRUCT WAS REMOVED DURING REVISION SURGERY, INCLUDING TRICORTICAL ILIAC WEDGE (12 X 12 X 9). THERE WAS NO EVIDENCE OF FUSION AT THIS TIME. DOCTOR REMOVED ENTIRE TRINICA CONSTRUCT AND BONE WEDGE, HOWEVER THE BROKEN SCREW PIECE REMAINS IMPLANTED WITHIN THE VERTEBRAL BODY. THE SURGEON REPLACED THE CONSTRUCT WITH NEW BONE AND A NON-ZIMMER FIXATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINICA ANTERIOR CERVICAL PLATE SYSTEM TRINICA 16MM VARIABLE ANGLE SCREW HWQ ZIMMER SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other DONOR BONE GRAFT (TRICORTICAL ILIAC WEDGE) -| TUTOGEN.