BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIANA TOME

    MDR report key: 374864 · Received January 31, 2002

    Report

    Report Number
    1825034-2002-00011
    Event Type
    Injury
    Date Received
    January 31, 2002
    Date of Event
    October 18, 1999
    Report Date
    January 30, 2002
    Manufacturer
    BIOMET, INC.
    Product Code
    EKD
    Removal / Correction Number
    NOT APPLICABLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT CARPAL TUNNEL RELEASE PROCEDURE UTILIZING INDIANA TOME IN 1999. SUBSEQUENTLY, IT WAS DETERMINED THAT THE MEDIAN NERVE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDIANA TOME INSTRUMENT, MANUAL, SURGICA EKD BIOMET, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R NOT APPLICABLE.