BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK CUFFTACK SUTURLESS ANCHOR

    MDR report key: 478532 · Received August 20, 2003

    Report

    Report Number
    1221934-2003-00083
    Event Type
    Injury
    Date Received
    August 20, 2003
    Date of Event
    June 23, 2003
    Report Date
    June 23, 2003
    Manufacturer
    MITEK WORLDWIDE
    Product Code
    MAI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    2X CUFFTACKS IN PTS SHOULDER. AT 7 WEEKS NRI SCAN SHOWED CUFFTACKS HAD SNAPPED AND WERE LOOSE IN SHOULDER AND HAD CAUSED 2 TEARS IN THE SUPRASPINATUS TENDON?.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK CUFFTACK SUTURLESS ANCHOR SOFT TISSUE FIXATION DEVICE MAI MITEK WORLDWIDE 251120 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention