BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA CLOSURE TOP

    MDR report key: 1950180 · Received December 9, 2010

    Report

    Report Number
    1649384-2010-00174
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L RELEVANT INFO WILL BE PROVIDED WHEN THE DEVICE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT L5-S1 FUSION HAD FAILED. UPON REVISION, IT WAS FOUND THAT THE CLOSURE TOP WAS LOOSE. NEW HARDWARE WAS IMPLANTED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUOIA CLOSURE TOP CLOSURE TOP NKB ZIMMER SPINE 3301-1 57XR

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR SEQUOIA 6.5MMX45MM SCREW (PART NUMBER: (B)(4))