BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINICA FIXED SCREW 4.2 X 14 MM

    MDR report key: 4360566 · Received December 18, 2014

    Report

    Report Number
    2184052-2014-00199
    Event Type
    Injury
    Date Received
    December 18, 2014
    Report Date
    November 21, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER IMPLANTED DEVICES: 07.00119.003 - TRINICA FIXED SCREW 4.2 X 16 MM, 07.00117.002 - TRINICA VARIABLE SCREW 4.2 X 14 MM, 07.01616.006 - INVIZIA 2-LEVEL ACDF PLATE 44 MM. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THIS COMPLAINT DEVICE COULD NOT BE VIEWED. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN POSSIBLY DUE TO METAL ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831404 TRINICA FIXED SCREW 4.2 X 14 MM TRINICA FIXED SCREW 4.2 X 14 MM KWQ ZIMMER SPINE, INC. 07.00119.002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention