BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA FINAL DRIVER (PLE)

    MDR report key: 2553895 · Received April 25, 2012

    Report

    Report Number
    1649384-2012-00036
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 26, 2012
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    Removal / Correction Number
    1649384-02/28/2011-01-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL RELEVANT INFORMATION WILL BE PROVIDED WHEN THE DEVICE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, TWO SEQUOIA DRIVERS STRIPPED. LEVELS TREATED WERE L3-L5 FOR GRADE 1 SPONDYLOLYSIS. WHILE TIGHTENING THE SET SCREWS AT THE END OF THE CASE, BOTH FINAL DRIVERS IN THE SET STRIPPED. THERE WERE NO OTHER INSTRUMENTS AVAILABLE FOR USE DURING FINAL TIGHTENING. THE SET SCREWS WERE LEFT IN PLACE AND THE CASE CLOSED. THE DELAY TO THE CASE WAS ONLY A FEW MINUTES AND THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUOIA FINAL DRIVER (PLE) SEQUOIA FINAL DRIVER (PLE) NKB ZIMMER SPINE 3384-2 61HZ

    Patients

    Seq Age Sex Outcome Treatment
    1