BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTELON TISSUE REINFORCEMENT

    MDR report key: 4068013 · Received August 11, 2014

    Report

    Report Number
    3010673515-2014-00001
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 14, 2014
    Report Date
    August 8, 2014
    Manufacturer
    INTERNATIONAL LIFE SCIENCES D/B/A/ ARTELON
    Product Code
    FTL
    PMA / PMN Number
    K071887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS DID NOT SHOW ANY ANOMALY THAT COULD HAVE CONTRIBUTED TO THE ALLEGED INFECTION. DUE TO THE FACT THAT RTI ACHILLES TENDON ALLOGRAFT WAS USED IN CONJUNCTION WITH THE ARTELON TISSUE REINFORCEMENT PATCH, IT IS PROBABLE THAT OTHER DEVICES OR SURGICAL PREPARATION WERE THE CAUSE OF THE INFECTION.

    Description of Event or Problem · 1

    PT PRESENTED WITH A CALCIFIED PATELLAR TENDON WHICH WAS SURGICALLY REMOVED (B)(6) 2014 AND REPLACED WITH AN RTI ACHILLES TENDON ALLOGRAFT AND AUGMENTED ARTELON TISSUE REINFORCEMENT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 DUE TO APPARENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476057 ARTELON TISSUE REINFORCEMENT TISSUE REINFORCEMENT PATCH FTL INTERNATIONAL LIFE SCIENCES D/B/A/ ARTELON 1304003997

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention