BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 512000 · Received February 18, 2004

    Report

    Report Number
    512000
    Event Type
    Injury
    Date Received
    February 18, 2004
    Date of Event
    January 24, 2004
    Report Date
    February 6, 2004
    Manufacturer
    BIOMET, INC.
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    EXPLANTED 4 HOLE PLATE LAG SCREW WITH 4 SCREWS DUE TO FAILURE (L) HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET PLATE, LEG SCREWS 4 SCREWS KTT BIOMET, INC. * 200108
    2 BIOMET LEG SCREW 12.7 X 95 KTT BIOMET, INC. * 375960
    3 BIOMET 38 MM SCREW X 3 KTT BIOMET, INC. * *
    4 BIOMET 48 MM SCRE X 1 KTT BIOMET, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention