BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUOIA CLOSURE TOP

    MDR report key: 5634389 · Received May 5, 2016

    Report

    Report Number
    0002184052-2016-00042
    Event Type
    Injury
    Date Received
    May 5, 2016
    Date of Event
    March 31, 2016
    Report Date
    April 8, 2016
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK131980
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. REPORT TWO OF THREE FOR THE SAME EVENT, REFERENCE 0002184052-2016-00041-1 AND 0002184052-2016-00062.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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. REPORT TWO OF TWO FOR THE SAME EVENT; SEE ALSO 0002184052-2016-00041. THE ROD PART NUMBER IS UNKNOWN, IF IT IS RECEIVED AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY EVALUATED REVEALING THAT THE CLOSURE TOP HAD SOME MATERIAL DISPLACEMENT ON THE BOTTOM SIDE WHICH CONTACTS THE ROD AND THE DISTAL THREADS ARE SLIGHTLY BENT. THIS DISPLACEMENT OCCURS ON ONLY ONE SIDE OF THE CLOSURE TOP SUGGESTING THAT IT WAS NOT SEATED FULLY WITHIN THE TULIP HEAD. THE COMPLAINT IS CONFIRMED. THE DHR SHOWS THAT THERE WERE NO NONCONFORMANCES OR MANUFACTURING ISSUES NOTED THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER, CROSS THREADING OF THE CLOSURE TOP WAS LIKELY A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED THAT AFTER A SURGERY, A REVISION SURGERY HAD TO BE PERFORMED DAYS LATER TO REPLACE A BROKEN SCREW THAT WAS DISCOVERED WITH AN X-RAY. IN ORDER TO REMOVE THE BROKEN SCREW, THREE CLOSURE TOPS AND THE ROD HAD TO BE REMOVED. THEY REPLACED THE ROD WITH A NEW ONE AND CHANGED THE THREE CLOSURE TOPS WITH NEW ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289432 SEQUOIA CLOSURE TOP CLOSURE TOP NKB ZIMMER SPINE N/A 85GQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R