BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURITY BLADE

    MDR report key: 644123 · Received October 25, 2005

    Report

    Report Number
    644123
    Event Type
    Injury
    Date Received
    October 25, 2005
    Date of Event
    September 22, 2005
    Report Date
    October 24, 2005
    Manufacturer
    BIOMET ORTHOPAEDICS
    Product Code
    EKD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RIGHT CARPAL TUNNEL RELEASE PERFORMED. PATIENT RETURNED HOME. PATIENT RETURNED 2005 WITH NUMBNESS IN RIGHT INDEX FINGER. RIGHT MEDIAN NERVE HAD BEEN PARTIALLY CUT. NERVE WAS REPAIRED AND PATIENT RELEASED TO HOME WITHOUT FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURITY BLADE CARPAL TUNNEL RELEASE SYSTEM EKD BIOMET ORTHOPAEDICS * 603460

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention