BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAD RING DRIVE (BWR & CRW)

    MDR report key: 2445326 · Received January 27, 2012

    Report

    Report Number
    1222895-2012-00002
    Event Type
    Malfunction
    Date Received
    January 27, 2012
    Report Date
    January 27, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION AS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A HEAD RING DRIVE (BRW AND CRW) BROKE OFF DURING SET-UP FOR A PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEAD RING DRIVE (BWR & CRW) NA HAW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1