BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROFIX QUICKANCHOR PLUS

    MDR report key: 1349816 · Received March 23, 2009

    Report

    Report Number
    1221934-2009-00101
    Event Type
    Injury
    Date Received
    March 23, 2009
    Report Date
    March 10, 2009
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT HE RECEIVED A PHONE CALL FROM A SURGEON WHO DETAILED THAT HE HAD INSERTED A 212856 MICROFIX IN A PT FOR FIXATION APRPOX. 6 MONTHS AGO AND THE PT HAS PRESENTED WITH SOME SORT OF REACTION. AT THIS POINT IN TIME THIS IS THE EXTENT OF THE INFO GIVEN TO MITEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROFIX QUICKANCHOR PLUS SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 212856 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention