BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUOIA

    MDR report key: 1002562 · Received February 26, 2008

    Report

    Report Number
    1649384-2008-00070
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    ON 29 OF JAN 2008, THE SALES REPRESENTATIVE REPORTED THAT DURING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SURGERY, THE SURGEON WAS TIGHTENING THE CLOSURE TOP WHEN BOTH DRIVERS STRIPPED CAUSING THE CLOSURE TOP INTERNAL THREADS TO STRIP. THE SURGEON INTERVENED AND EXPLANTED THE SHEARED CLOSURE TOPS, IMPLANTING NEW ONES. THERE WAS A 20 MINUTES DELAY IN THE CASE. ADDITIONAL INFORMATION RECEIVED ON 30 JAN 2008 VIA TELEPHONE, THE SALES REPRESENTATIVE REPORTED, THAT ON THE FINAL TIGHTENING OF THE CLOSURE TOPS, THE TWO DRIVERS STRIPPED. THE INTERNAL THREAD OF THE CLOSURE TOPS ALSO SHEARED. THE THREE CLOSURE TOPS WERE EXPLANTED AND THE SURGEON IMPLANTED NEW ONES. THE SURGEON HAD TO USE FORCE TO GET THE DRIVERS TO FULLY LOCK THE NEW CLOSURE TOPS. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUOIA SEQUOIA CLOSURE TOP KWP ABBOTT SPINE, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention