BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGIDFIX 3.3MM CROSS PIN KIT

    MDR report key: 1122753 · Received August 18, 2008

    Report

    Report Number
    1221934-2008-00400
    Event Type
    Injury
    Date Received
    August 18, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 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 TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND EVALUATED, THE RESULTS WILL BE THE SUBJECT OF THE F/U REPORT.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING THAT A PT HAD A KNEE REPAIR WITH THE USE OF MITEK RIGIDFIX CROSS PINS FOR FIXATION SOMETIME IN 2006. PT WAS OK AT 1 YR POST-OP IN 2007, HOWEVER, AT SOME POINT AFTER THAT, ONE OR BOTH OF THE CROSS PINS BROKE AND MIGRATED INTO THE KNEE JOINT SPACE. IN 2008, A RE-SURGERY WAS PERFORMED. [AT THIS POINT IN TIME THIS IS ALL THE INFO THAT HAS BEEN MADE AVAILABLE TO US. QUESTIONS OUT TO OUR AFFILIATE FOR FURTHER DETAIL AND CLARITY.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIDFIX 3.3MM CROSS PIN KIT SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 210333 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention