BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINICA CERVICAL BONE TAP

    MDR report key: 1550715 · Received November 20, 2009

    Report

    Report Number
    2184052-2009-00086
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    October 21, 2009
    Report Date
    October 21, 2009
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    HWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF EVALUATION. BATCH RECORD REVIEW INDICATED THAT THE DEVICE WAS MANUFACTURED TO ALL APPLICABLE SPECIFICATIONS AND REQUIREMENTS.

    Description of Event or Problem · 1

    THE TAP BROKE IN THE VERTEBRAL BODY. IT WAS DRILLED OUT OF THE HOLE AND THE BROKEN PIECE OF TAP WAS RETRIEVED FROM THE PATIENT. A PLATE WAS NOT PUT ON DUE TO THE LOSS OF VIABLE BONE FROM DRILLING OUT THE HOLE. THE SURGEON LEFT IN THE BONE AND COLLARED THE PATIENT FOR 6 WEEKS. THERE WAS NO SIGNIFICANT ADDITIONAL SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINICA CERVICAL BONE TAP TRINICA CERVICAL BONE TAP HWX ZIMMER SPINE, INC. 07.00168.001 P080749

    Patients

    Seq Age Sex Outcome Treatment
    1