BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.2X12MM FIXED SCR TRINIC

    MDR report key: 2852865 · Received November 27, 2012

    Report

    Report Number
    2184052-2012-00029
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 9, 2010
    Report Date
    October 29, 2012
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    LEGAL CLAIM REPORTED: THE PATIENT ORIGINALLY UNDERWENT PROCEDURE TO FUSE THREE LEVELS DUE TO INJURY RESULTING FROM A WORK ACCIDENT. APPROXIMATELY TWELVE DAYS POST-OP, THE PATIENT PRESENTED WITH PAIN AND REDUCED MOVEMENT IN THE UPPER EXTREMITIES. INVESTIGATION FOUND AT C6 THERE WAS A "PROTRUDING SCREW". THE SCREW WAS REMOVED AND REPLACED. APPROXIMATELY EIGHT DAYS LATER, IT WAS FOUND THE SCREW WAS OUT OF PLACE A THE SAME LEVEL. AN ATTEMPT WAS MADE TO REMOVE THE PLATE AND SCREWS BUT WAS UNSUCCESSFUL. ONE MONTH LATER, THE PATIENT UNDERWENT ANOTHER REVISION PROCEDURE IN WITH THE SCREW WAS REMOVED AND REPLACED. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.2X12MM FIXED SCR TRINIC 4.2X12MM FIXED SCR TRINIC MCV ZIMMER SPINE, INC. 07.00119.001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR