BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRINICA ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 594708 · Received December 10, 2004

    Report

    Report Number
    2184052-2004-00018
    Event Type
    Other
    Date Received
    December 10, 2004
    Date of Event
    November 9, 2004
    Report Date
    December 10, 2004
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WENT IN FOR CERVICAL FUSION SURGERY AT C5-C7 FOR IMPLANTATION OF TWO CERVICAL INTERBODY FUSION DEVICES AND ONE TWO LEVEL TRINICA ANTERIOR CERVICAL PLATE. DURING DRILLING OF ONE OF THE HOLES FOR THE PLATE THE SURGEON WAS DRILLING WITH THE AID OF A VARIABLE ANGLE DRILL GUIDE AND THE TIP OF THE DRILL BIT BROKE OFF IN THE PTS CERVICAL VERTEBRAE. THE SURGEON COMMENTED TO THE REP. PRIOR TO DRILLING THAT THE DRILL GUIDE APPEARED BENT, BUT THEN USED IT ANYWAY. THE REP. STATED THAT THE SURGEON WAS APPLYING LATERAL FORCE IN ORDER TO OPERATE THE DRILL THROUGH THE BENT DRILL GUIDE WHEN THE DRILL BIT BROKE OFF. THE SURGEON LEFT THE BROKEN TIP OF THE DRILL BIT IN THE PT'S VERTEBRAE, COMMENTING THAT IT WOULD DO MORE HARM THAN GOOD IN ATTEMPTING TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINICA ANTERIOR CERVICAL PLATE SYSTEM TRINICA DISPOSABLE DRILL BIT HTW ZIMMER SPINE, INC. 07.00166.01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other