BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2008865 · Received February 24, 2011

    Report

    Report Number
    2008865
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    June 4, 2010
    Report Date
    February 24, 2011
    Manufacturer
    STRYKER INSTRUMENTS DIV. OF STRYKER CORPORATION
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    STRYKER 3.0MM ROUND MIS BURR REF# 8420-10-30, TIP BROKE OFF DURING FUSION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS DIV. OF STRYKER CORPORATION 8420-10-30 3121201093520178-Z

    Patients

    Seq Age Sex Outcome Treatment
    1 *