BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA DRIVE

    MDR report key: 885286 · Received July 20, 2007

    Report

    Report Number
    MW5003141
    Event Type
    Injury
    Date Received
    July 20, 2007
    Date of Event
    July 11, 2007
    Report Date
    July 20, 2007
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ULTRA DRIVE 7.0 MM DISK DRIVE TOOL BEING USED TO REMOVE CEMENT FROM RIGHT FEMUR SHAFT, BROKE OFF AT THE TIP X2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA DRIVE 7.0 MM DISK DRILL TOOL LZV BIOMET ORTHOPEDICS 423871 779930
    2 ULTRA DRIVE 7.0 MM DISK DRILL TOOL LZV BIOMET ORTHOPEDICS 423871 860100

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability