BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO QA+, 3-0 ETHBND (V4) W/1.3MM BIT

    MDR report key: 1790783 · Received August 4, 2010

    Report

    Report Number
    1221934-2010-00276
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    July 4, 2010
    Report Date
    July 27, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS POINT IN TIME, MITEK IS IN THE GATHERING INFORMATION MODE. IF AND WHEN MORE INFORMATION BECOMES AVAILABLE, THEN MITEK WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    DOCTOR HAD TO REMOVE MICRO ANCHOR FROM PATIENT, FOR THEY WERE EXPELLED FROM BONE, DUE TO A FOREIGN BODY REACTION WERE CYSTS HAD FORMED. THE ANCHORS REMOVED HAD BEEN PLACED IN PHALANGES 3 AREA OF THE FINGER. COMPLAINT DEVICES DISCARDED BY USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO QA+, 3-0 ETHBND (V4) W/1.3MM BIT MICRO QA+ ANCHOR MBI DEPUY MITEK 212865 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention