BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA

    MDR report key: 4023537 · Received August 15, 2014

    Report

    Report Number
    2184052-2014-00134
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THIS EVENT, NO DEVICES OR ADDITIONAL INFORMATION WAS RECEIVED. REVIEW OF INFORMATION PROVIDED AND ANALYSIS OF RETURNED DEVICES FOR SIMILAR EVENTS REPORTED BY THE SAME SITE CONCLUDED THAT THERE IS NO EVIDENCE OF A PRODUCT DEFECT. A ROOT CAUSE IS UNABLE TO BE DETERMINED. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IN RESPONSE TO FOLLOW UP QUESTIONS DURING AN INVESTIGATION FOR COMPLAINTS ALLEGING LOOSE SEQUOIA CONSTRUCTS, IT WAS INDICATED BY THE SURGEON THAT HE WAS AWARE OF ADDITIONAL PATIENTS WITH SIMILAR ISSUES. IT WAS ALSO INDICATED AT THIS TIME THAT NO ADDITIONAL INFORMATION WOULD BE PROVIDED. BASED ON THE COMMUNICATION FROM THE SURGEON, ADDITIONAL COMPLAINTS WERE REGISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491313 SEQUOIA SEQUOIA IMPLANT GENERIC KWP ZIMMER SPINE 3300 SEQUOIA IMPLANT

    Patients

    Seq Age Sex Outcome Treatment
    1