BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRA - DRIVE DISK DRILL

    MDR report key: 575380 · Received February 23, 2005

    Report

    Report Number
    1825034-2005-00016
    Event Type
    Other
    Date Received
    February 23, 2005
    Date of Event
    February 14, 2005
    Report Date
    February 16, 2005
    Manufacturer
    BIOMET, INC.
    Product Code
    LZV
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE UTILIZING CEMENT REMOVAL SYSTEM, THE DISK DRILL TIP FRACTURED. SURGEON ELECTED NOT TO REMOVE TIP FROM PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA - DRIVE DISK DRILL CEMENT REMOVAL SYSTEM LZV BIOMET, INC. NA 784490

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other