BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUPUY MITEK

    MDR report key: 855102 · Received May 18, 2007

    Report

    Report Number
    MW5001935
    Event Type
    Injury
    Date Received
    May 18, 2007
    Date of Event
    January 15, 2003
    Report Date
    May 18, 2007
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIOKNOTLESS ANCHORS WERE USED FOR A POSTERIOR LATERAL STABILIZATION OF THE RIGHT SHOULDER. PATIENT CONTINUES TO COMPLAIN OF PAIN AND STIFFNESS, WITH A FOLLOW UP ARTHROSCOPY DONE IN 2003 FOR LYSIS OF ADHESIONS. AFTER CONTINUING COMPLAINTS OF PAIN, STIFFNESS, AND LOSS OF MOBILITY, AN ARTHROGRAM WITH AN MRI WAS ORDERED WHEN XRAYS APPEAR NORMAL. MRI WAS RENDERED UNDIAGNOSTIC, WHEN A METAL OBJECT APPEARED TO BE PRESENT. CT DONE AT HOSP IN 2006 REPORTS A METALLIC DENSITY IN THE SOFT TISSUES MEDIAL TO THE SHOULDER. FOLLOW UP WAS DONE IN ANOTHER CITY, WITH SURGERY TO REMOVE THE METAL DONE IN ANOTHER PART OF THE COUNTRY, WHERE THE PATIENT NOW ATTENDS COLLEGE. THIS SURGERY WAS DONE THREE MONTHS LATER. CURRENTLY ON FILE IS A PICTURE OF WHAT APPEARS TO BE THE END OF AN INSERTER THAT IS USED TO PLACE THIS ITEM DURING THE INITIAL REPAIR. MODEL NUMBER 212729 WITH LOTS FROM BOTH 0209139 AND 0212159 WERE USED IN THE ORIGINAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUPUY MITEK BIOKNOTLESS ANCHOR MAI DEPUY MITEK 212729 0209139
    2 DUPUY MITEK BIOKNOTLESS ANCHOR MAI DEPUY MITEK 212729 0212159

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Disability RECORDS AT ANOTHER FACILITY. UNKNOWN WHAT THERAPY| WAS NEEDED.