BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 541589 · Received September 1, 2004

    Report

    Report Number
    541589
    Event Type
    Injury
    Date Received
    September 1, 2004
    Date of Event
    March 1, 2004
    Report Date
    August 20, 2004
    Manufacturer
    *
    Product Code
    KWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO HOSP FOR ARTHRODESIS OF LEFT WRIST WITH BONE GRAFT AND REMOVAL OF SILASTIC WRIST IMPLANT. ORIGINAL IMPLANT WAS PLACED 1987. INDICATIONS FOR PT'S SURGERY WERE CHRONIC SEVERE PAIN, LIMITED MOTION, EXTENSIVE EROSIONS OF THE CARPUS AND DISTAL RADIUS AND ULNA. THIS WAS SECONDARY TO SILICONE EROSION AND SEVERE FUNCTIONAL LIMITATIONS SECONDARY TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SILASTIC WRIST PROSTHESIS KWM * UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention