BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOINTRAFIX SCREW

    MDR report key: 1212577 · Received October 24, 2008

    Report

    Report Number
    1221934-2008-00486
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 14, 2008
    Report Date
    October 15, 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 AT THIS POINT IN THE TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD IS HAD AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT OF A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT A PATIENT UNDERWENT AN ACL REPAIR IN 2008. SUBSEQUENT TO THIS PROCEDURE THE PATIENT DEVELOPED REDNESS AND SWELLING AROUND THE WOUND SITE. THE SITE WAS RE-VISITED IN 2008, THE SURGEON NOTED THAT THE TIBIAL FIXATION DEVICE HAD BACKED OUT OF THE TIBIA AND THE TUNNEL WAS FILLED WITH PUSS. THE SURGEON COMMENTED THAT THE SCREW APPEARED AS THOUGH IT WAS RESORBING RATHER RAPIDLY. ALSO NOTED WAS THE FACT THAT THERE APPEARED TO BE SOME OSTEOLYSIS HAPPENING, THE TIBIAL BONE TUNNEL HAD GROWN FROM THE ORIGINAL 8MM DIAMETER TO ROUGHLY 25MM. THE SURGEON REMOVED THE FIXATION DEVICE AND DISCARDED. [POST SCRIP: THIS IS ALL OF THE INFORMATION THAT HAS AT THIS POINT IN TIME BEEN MADE AVAILABLE TO MITEK. QUESTIONS ARE OUT TO THE MITEK REP FOR FURTHER INFORMATION AND CLARITY. ..AFRIGAULT 17-OCT-2008 12:46:09] ALSO SEE ASSOCIATED MDR 1221934-2008-00485.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOINTRAFIX SCREW SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 254660 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention