BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK MINI ANCHOR

    MDR report key: 551813 · Received August 4, 2004

    Report

    Report Number
    MW1032930
    Event Type
    Injury
    Date Received
    August 4, 2004
    Report Date
    August 4, 2004
    Manufacturer
    DEPUY MITEK / JOHNSON & JOHNSON CO.
    Product Code
    MBI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2003 PT REC'D MITEK ANCHOR IMPLANTED IN THE TEMPOROMANDIBULAR JOINT AREA. SHORTLY AFTERWARD PT EXPERIENCED SEVERE DEEP ITCHING ALONG SURGICAL SITE AND POPPING AND PAIN IN THE TMJ AREA. IN 2004 UNDERWENT SURGERY AGAIN AND IT WAS FOUND THAT BOTH TM DISCS WERE DISPLACED AND THE LEFT DISC HAD FOLDED OVER AND FELL APART WHERE THE MITEK ANCHORS HAD BEEN IMPLANTED IN 2003. MITEK ANCHORS CALCIFIED AND THE LEFT-SIDE DISINTEGRATED SO SURGEON WAS UNABLE TO REMOVE MITEK ANCHORS AND REMOVED THE DAMAGED DISCS. FOUR WEEKS AFTER THE SECOND SURGERY AND THE SEVERE ITCHING CONTINUES.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/16/2004: THERE WAS NO PRODUCT CODE LISTED ON THE ENCLOSED FORM. HOWEVER BASED ON THE TYPE OF PROCEDURE DESCRIBED AND PRODUCT DESCRIPTION PROVIDED IN VOLUNTARY REPORT MW1032930, DEPUY MITEK WILL ASSUME THE PRODUCT CODE IS 212033. NO MEDWATCH REPORT WAS FILED UNTIL NOTIFICATION OF THIS EVENT. UPON RECEIVING LETTER A MEDWATCH REPORT WAS FILED VIA FAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK MINI ANCHOR BONE ANCHOR USED TO SECURE TM DISCS IN PLACE MBI DEPUY MITEK / JOHNSON & JOHNSON CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention