BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIANA TOME SYSTEM

    MDR report key: 1025157 · Received April 4, 2008

    Report

    Report Number
    1825034-2008-00093
    Event Type
    Injury
    Date Received
    April 4, 2008
    Report Date
    March 10, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    EKD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. THIS REPORT FILED ON APRIL 4, 2008.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT DURING PROCEDURE USING INDIANA TOME SYSTEM, THE NERVE IN HIS LEFT HAND WAS CUT. NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability