BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPEDICS, INC

    MDR report key: 423496 · Received October 15, 2002

    Report

    Report Number
    423496
    Event Type
    Injury
    Date Received
    October 15, 2002
    Date of Event
    October 8, 2002
    Report Date
    October 15, 2002
    Manufacturer
    BIOMET ORTHPEDICS, INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS SEEN BY ORTHOPEDIST IN 2002 AND X-RAYS FOUND SCREW INTACT. PT SEEN IN HOSPITAL EMERGENCY DEPT IN 2002 AND SCREW WAS FOUND TO BE BROKEN. SURGERY PERFORMED 3 DAYS LATER TO REMOVE BROKEN SCREW AND REPLACE WITH NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS, INC LAG SCREW HWC BIOMET ORTHPEDICS, INC * 102540

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| O| R