BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BANKART TACK

    MDR report key: 856775 · Received May 25, 2007

    Report

    Report Number
    9613278-2007-00022
    Event Type
    Malfunction
    Date Received
    May 25, 2007
    Date of Event
    June 1, 2000
    Report Date
    March 28, 2007
    Manufacturer
    CONMED LINVATEC BIOMATERIALS LTD
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU

    Narratives

    Additional Manufacturer Narrative · 1

    WE WILL NOT RECEIVE THE IMPLANT BACK, SO WE CAN NOT MAKE ANY INVESTIGATION OR CONCLUSIONS.

    Description of Event or Problem · 1

    PATIENT SUFFERED PAIN AND MASSIVE WATER IN HIS HUMERAL JOINT AFTER OPERATION. A RE-ARTHROSCOPY WAS CONDUCTED 5 MONTHS AFTER INITIAL OPERATION AND IN THIS OPERATION THERE WAS NOT ANY STABLE IMPLANTS FOUND, ONLY TWO HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BANKART TACK BIOABSORBABLE SOFT TISSUE FIX DEVICE MAI CONMED LINVATEC BIOMATERIALS LTD 969

    Patients

    Seq Age Sex Outcome Treatment
    1 YR NK