BEUDAMED
    FDA Adverse Event Other Summary report: N

    BANKART TACK

    MDR report key: 643872 · Received October 31, 2005

    Report

    Report Number
    9613278-2005-00019
    Event Type
    Other
    Date Received
    October 31, 2005
    Date of Event
    August 5, 2005
    Report Date
    October 28, 2005
    Manufacturer
    LINVATEC BIOMATERIALS LTD,
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A SHOULDER SURGERY IN 2005. FOUR MONTHS LATER HE COMPLAINED OF PAIN AND AN ACROMIOPLASTY WAS PERFORMED. DURING THAT SURGERY A PORTION OF THE DEVICE WAS FOUND IN BACK OF THE SHOULDER AND REMOVED. THE LABRUM WAS HEALED AND HAD GOOD FIXATION. NO INJURY OR ARTICULAR DAMAGE CAUSED BY THE IMPLANT WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BANKART TACK BIOABSORBABLE SOFT TISSUE FIXATION DEVICE MAI LINVATEC BIOMATERIALS LTD, 523520 S0001872

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention