BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VILEX IMPLANT

    MDR report key: 7034804 · Received November 15, 2017

    Report

    Report Number
    1051526-2017-00001
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    August 29, 2017
    Report Date
    November 10, 2017
    Manufacturer
    VILEX IN TENNESSEE, INC.
    Product Code
    KWD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE 11/10/2017, VILEX HAS NOT RECEIVED ANY ADDITIONAL INFORMATION FROM THE SALES REP OR THE DOCTOR REGARDING THE MALFUNCTION OF THIS IMPLANT.

    Description of Event or Problem · 1

    VILEX CONTACTED THE SALES REP BY PHONE AUGUST 29TH AND 30TH. SALES REP STATED IT WAS DR. (B)(6) WHO HAD A PATIENT WITH AN IMPLANT THAT HAS BEEN IMPLANTED FOR ABOUT 2 YEARS AND THE IMPLANT WAS NOW BROKEN IN THE TOE AND HAD NOT BEEN REMOVED. VILEX EMAILED THE SALES REP AGAIN ASKING FOR AN ISSUE REVIEW FORM TO BE COMPLETED ON AUGUST 30, 2017. ON SEPTEMBER 8, 2017 VILEX ASKED SALES REP TO PLEASE GIVE MORE INFORMATION AND COMPLETE THE FORM. ON SEPTEMBER 8, 2017, SALES REP SUBMITTED THE FORM, CONTAINING VERY LITTLE INFORMATION, REPORTING A LESSER MET HEMI WAS BROKEN. AT THE TIME OF THIS REPORT, THIS IS ALL THE KNOWN INFORMATION THAT VILEX HAS ACQUIRED. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD VILEX RECEIVE MORE INFORMATION REGARDING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815114 VILEX IMPLANT VILEX IMPLANT KWD VILEX IN TENNESSEE, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1