BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIZIA ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 5815487 · Received July 22, 2016

    Report

    Report Number
    0002184052-2016-00132
    Event Type
    Malfunction
    Date Received
    July 22, 2016
    Date of Event
    June 6, 2016
    Report Date
    June 23, 2016
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWQ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. DEVICE PRODUCT CODE IS GFC. REFERENCE REPORTS 2184052-2016-00133 AND 2184052-2016-00134 FOR THE OTHER CASES REPORTED.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICES WERE EXAMINED. VISUAL EXAMINATION DETERMINED THE DEVICES WERE WORN AS THEY HAVE SCRATCHES AND DULL EDGES. THERE ARE NO INDICATIONS OF MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT IS REPORTED THE SURGEON PERFORMED THREE ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) CASES USING THREE DIFFERENT SETS, THE TWO HEX SCREWDRIVERS IN EACH SET WOULD NOT HOLD ONTO THE SCREWS DUE TO WEAR OF THE HEX HEAD. THE SURGEON APPLIED BONE WAX TO THE PERIMETER OF THE SCREW HEAD/SCREWDRIVER INTERFACE AND WAS ABLE TO FIXATE THE PLATE. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469978 INVIZIA ANTERIOR CERVICAL PLATE SYSTEM TRINICA LP HEX DRIVER KWQ ZIMMER SPINE N/A 62700510

    Patients

    Seq Age Sex Outcome Treatment
    1