BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-TRANSFIX, 5MM X 50MM

    MDR report key: 694919 · Received December 1, 2006

    Report

    Report Number
    1220246-2006-00175
    Event Type
    Injury
    Date Received
    December 1, 2006
    Date of Event
    October 25, 2006
    Report Date
    November 29, 2006
    Manufacturer
    ARTHREX, INC.
    Product Code
    MNU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH PAIN AND SWELLING AT INSERTION SITE APPROX 2 MONTHS POST-OP. PT'S KNEE WAS DRAINED AND ADMINISTERED VANCOMYCIN TO TREAT CONDITION. CULTURES SHOWED NO GROWTH. PT IS TO FOLLOW UP WITH HIS GENERAL DOCTOR. THIS DEVICE IS USED FOR TREATMENT.

    Description of Event or Problem · 1

    PT PRESENTED WITH PAIN AND SWELLING AT INSERTION SITE APPROX 2 MONTHS POST-OP. PT'S KNEE WAS DRAINED AND ADMINISTERED VANCOMYCIN TO TREAT CONDITION. CULTURES SHOWED NO GROWTH. PT IS TO FOLLOW UP WITH HIS GENERAL DOCTOR. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-TRANSFIX, 5MM X 50MM BIO-ABSORBABLE FIXATION DEVICE MNU ARTHREX, INC. NA 77433

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention