BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-DRIVE DISK DRILL

    MDR report key: 457722 · Received May 2, 2003

    Report

    Report Number
    1825034-2003-00063
    Event Type
    Injury
    Date Received
    May 2, 2003
    Report Date
    April 11, 2003
    Manufacturer
    ARTHROTEK/BIOMET
    Product Code
    LZV
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE UTILIZING THE ULTRA-DRIVE CEMENT REMOVAL SYSTEM, THE TIP OF THE 9.5MM DISK DRILL FRACTURED. SURGEON ELECTED NOT TO REMOVE TIP. THE DATE OF THE EVENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-DRIVE DISK DRILL CEMENT REMOVAL SYSTEM LZV ARTHROTEK/BIOMET NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other