BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOINTRAFIX SHEATH

    MDR report key: 1061682 · Received June 16, 2008

    Report

    Report Number
    1221934-2008-00305
    Event Type
    Injury
    Date Received
    June 16, 2008
    Report Date
    April 7, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD IS HAD AND EVALUATED, THE RESULTS OF THAT INVESTIGATION WILL BE SUBJECT OF THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR AFFILIATE REPORTS THAT A PT HAD A KNEE REPAIR SOMETIME IN 2005 OR 2006, WITH THE USE OF A BIOINTRAFIX SCREW AND SHEATH FOR TIBIAL FIXATION. APPROX 2 TO 3 YEARS LATER, IN 2008, THE PT PRESENTED WITH PAIN. AT APPROX THE SAME TIME FRAME, THE PT WAS EXAMINED, WE ASSUME THAT THE SITE WAS REVISITED SURGICALLY. THE SURGEON NOTED THAT THERE WAS "GRANULOSIS" AT THE SITE OF THE TIBIAL TUNNEL. THE SURGEON ALSO NOTED THAT THE SHEATH WAS NO LONGER PRESENT. THIS IS ALL OF THE INFO THAT HAS BEEN MADE AVAILABLE, THERE ARE QUESTIONS OUT TO THE COMPLAINT AUTHOR ASKING FOR FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOINTRAFIX SHEATH SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 254621 0508273

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other| R