BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH CE

    MDR report key: 1161259 · Received August 25, 2008

    Report

    Report Number
    1161259
    Event Type
    Malfunction
    Date Received
    August 25, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 25, 2008
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ORTHOPEDIC SURGEON WAS TAPPING IN THE LIGAMENT BALANCING SYSTEM, A PIECE BROKE OFF. NO RETAINED PIECES IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTECH CE LIGAMENT BALANCING SYSTEM, TOTAL KNEE LXI EXACTECH, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR