BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA FINAL DRIVER (PLE)

    MDR report key: 2182855 · Received July 8, 2011

    Report

    Report Number
    1649384-2011-00046
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    Removal / Correction Number
    1649384-02/28/2011-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED ROUNDED CORNERS ON THE HEX TIP. A FIELD ACTION, 1649384-02/28/2011-001C, TO INFORM USERS TO ENSURE COMPLETE INSTRUMENT ENGAGEMENT WITH THE CLOSURE TOP AND MAINTAIN ON AXIS DURING FINAL TIGHTENING HAS BEEN INITIATED. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED FOR THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, BOTH DRIVERS IN THE KIT WERE ROUNDED AND THE CLOSURE TOPS COULD NOT BE PROPERLY FINAL TIGHTENED. THERE WAS NO DELAY TO THE CASE AND NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUOIA FINAL DRIVER (PLE) FINAL DRIVER NKB ZIMMER SPINE 3384-2 60LL

    Patients

    Seq Age Sex Outcome Treatment
    1