BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-DRIVE DISK DRILL

    MDR report key: 235153 · Received August 9, 1999

    Report

    Report Number
    1825034-1999-00076
    Event Type
    Injury
    Date Received
    August 9, 1999
    Date of Event
    June 28, 1999
    Report Date
    August 5, 1999
    Manufacturer
    BIOMET, INC.
    Product Code
    LZV
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING UTILIZATION OF ULTRA DRIVE CEMENT REMOVAL SYSTEM ON 6/28/99, DISK PORTION OF TOOL FRACTURED WITHIN THE FEMORAL CANAL. SURGEON ELECTED TO WINDOW FEMUR TO EXTRACT TOOL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-DRIVE DISK DRILL CEMENT REMOVAL SYSTEM LZV BIOMET, INC. NA 307770

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention