BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-TRANSFIX, 5MM X 50MM

    MDR report key: 789978 · Received December 1, 2006

    Report

    Report Number
    1220246-2006-00177
    Event Type
    Injury
    Date Received
    December 1, 2006
    Date of Event
    November 14, 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

    Additional Manufacturer Narrative · 1

    IT IS UNK IF THE IMPLANT WAS REMOVED FROM THE PT, DHR REVIEW REVEALED NO ISSUES WITH THE STERILIZATION OF THIS PRODUCT. STAPH EPIDERMIDIS IS A COMMON INHABITANT OF THE SKIN. INFECTIONS REPORTED WITH THIS ORGANISM ARE TYPICALLY ACQUIRED IN THE HOSP MAINLY THROUGH SKIN WOUNDS AND/OR INDWELLED CATHETERS. THERE ARE NO OTHER COMPLAINTS FOR THIS PART / LOT NUMBER COMBINATION. THIS EVENT IS NOT CONSIDERED A PRODUCT RELATED ISSUE.

    Description of Event or Problem · 1

    PT PRESENTED WITH PAIN AND SWELLING AT INSERTION SITE AFTER ANTERIOR CRUCIATE LIGAMENT REPAIR. CULTURE SHOWED STAPH EPIDERMIDIS PRESENT. PT WAS ADMINISTERED VANCOMYCIN TO TREAT THE INFECTION. 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 77889

    Patients

    Seq Age Sex Outcome Treatment
    1 *