BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUET SUTURE ANCHOR

    MDR report key: 870224 · Received June 21, 2007

    Report

    Report Number
    9613278-2007-00026
    Event Type
    Malfunction
    Date Received
    June 21, 2007
    Report Date
    May 24, 2007
    Manufacturer
    CONMED LINVATEC BIOMATERIALS LTD
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US

    Narratives

    Additional Manufacturer Narrative · 1

    WE WILL NOT RECEIVE THE IMPLANT; THEREFORE, ANY INVESTIGATION OR CONCLUSION CAN'T BE MADE. IF ANY ADDITIONAL INFORMATION WILL BE RECEIVED, WE WILL PREPARE FOLLOW - UP REPORT ACCORDINGLY.

    Description of Event or Problem · 1

    A ROTATOR CUFF REPAIR PERFORMED BY DR. THE SUTURE CAME OUT OF THE ANCHOR. THE ANCHOR REMAINS IN THE PT'S SHOULDER AND WILL NOT BE COMING IN FOR EVAL. THE DOCTOR PLACED A SECOND ANCHOR, AND THE PROCEDURE WAS COMPLETED AS INTENDED WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUET SUTURE ANCHOR BIOABSORBABLE FIXATION DEVICE MAI CONMED LINVATEC BIOMATERIALS LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR