BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARLOTTE MTP FUSION PLATE

    MDR report key: 695366 · Received March 31, 2006

    Report

    Report Number
    1043534-2006-00032
    Event Type
    Malfunction
    Date Received
    March 31, 2006
    Date of Event
    February 1, 2006
    Report Date
    March 16, 2006
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KIG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY PRODUCT HAS NOT BEEN REMOVED FROM PT AS OF TODAY. SURGEON HAS NO PLANS TO DO UNLESS PT BEGINS TO HAVE PAIN. THE ABOVE PRODUCT PRESENTED TODAY ON X-RAYS AS BROKEN HARDWARE. IT APPEARS TO BE BROKEN THROUGH THE DISTAL OBLONG SCREW HOLE. SURGEON USED A 3.00 MUC SCREW FOR JOINT FIXATION WHICH IS NOT BROKEN. THIS PT IS ABOUT 6 WEEKS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARLOTTE MTP FUSION PLATE SMALL JOINT COMPONENT KIG WRIGHT MEDICAL TECHNOLOGY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other