BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILAGRO SCREW

    MDR report key: 1800885 · Received August 10, 2010

    Report

    Report Number
    1221934-2010-00268
    Event Type
    Injury
    Date Received
    August 10, 2010
    Report Date
    July 19, 2010
    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 THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A F/U REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT THE SURGEON, DR (B)(6), CONTACTED HIM ON JULY 19, 2010, TO REPORT AN ISSUE. THE SURGEON STATES THAT HE PERFORMED AN ACL REPAIR APPROXIMATELY 4 YEARS AGO (SOMETIME IN 2005 / 2006) ON A (B)(6) WOMAN. FOR FIXATION HE USED AN ANTERIOR TIBIALIS ALLOGRAFT AND 2 UNSPECIFIED MILAGRO SCREWS. RECENTLY, THE PT HAS BEEN HAVING WHAT SEEMS LIKE AN ALLERGIC SKIN REACTION (REDNESS, SWELLING). TEST PERFORMED AND INFECTION RULED OUT. THE SURGEON WANTS TO SEE IF THE BR MATERIAL IS THE ROOT CAUSE OF THE REACTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention