BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAFIX TIBIAL SHEATH, 30MM

    MDR report key: 1001098 · Received February 22, 2008

    Report

    Report Number
    1221934-2008-00099
    Event Type
    Injury
    Date Received
    February 22, 2008
    Report Date
    February 22, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS POINT IN TIME, WE HAVE VERY LITTLE DETAIL OF THE REPORTED EVENT AVAILABLE TO US. WE ARE IN DIALOGUE WITH OUR AFFILIATE TO TRY AND UNDERSTAND THE WHAT'S, WHEN'S AND WHERE'S OF THE ISSUE. A FOLLOW UP WILL BE SUBMITTED WITH CLEARER DETAILS.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING THAT ONE OF THEIR ACCOUNT FACILITIES HAS REPORTED TO THEM, WHAT WE BELIEVE TO BE, 4 CASES OF POST OPERATIVE REACTION. ORIGINAL KNEE REPAIRS WITH THE USE OF INTRAFIX SCREWS AND SHEATHS OF FIXATION WERE PERFORMED ON UNDETERMINED DATES & TIMES. IN EACH CASE, THE PTS PRESENTED TWO WEEKS POST OPERATIVELY WITH FEVER, AND SWELLING OF THE KNEE. SYNOVIAL FLUID CULTURED NEGATIVELY. AT THIS POINT IN TIME, THIS IS ALL OF THE INFO THAT IS AVAILABLE TO US. DIALOG WITH AFFILIATE IS ON GOING. SEE ALSO ASSOCIATED MDRS, 1221934-2008-00100, 1221934-2008-00101, 1221934-2008-00102, 1221934-2008-00103, 1221934-2008-00104, 1221934-2008-00105 AND 1221934-2008-00106.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAFIX TIBIAL SHEATH, 30MM SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 254601 0703100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention