BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLARUS PLUS HUMERAL ROD

    MDR report key: 544815 · Received September 17, 2004

    Report

    Report Number
    544815
    Event Type
    Other
    Date Received
    September 17, 2004
    Date of Event
    August 22, 2004
    Report Date
    September 1, 2004
    Manufacturer
    ACUMED/POLARUS, SEA PEARL, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE POLARUS LONG DRILL BIT BROKE OFF INSIDE THE BONE WHILE DRILLING. TIP WAS LEFT INSIDE AND USED AS A SCREW FOR THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARUS PLUS HUMERAL ROD DRILL BIT HTW ACUMED/POLARUS, SEA PEARL, INC. HR-0826-S W14502

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other