BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 938200 · Received October 5, 2007

    Report

    Report Number
    938200
    Event Type
    Malfunction
    Date Received
    October 5, 2007
    Date of Event
    October 5, 2007
    Report Date
    October 5, 2007
    Manufacturer
    TEDAN SURGICAL INNOVATIONS, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A CERVICAL DISC ARTHROPLASTY WHEN A PORTION OF THE DISTAL TIP OF A CERVICAL DISTRACTION PIN BROKE OFF AND REMAINS IN THE PATIENT'S SPINE. ACCORDING TO THE PHYSICIAN, THERE IS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CERVICAL DISTRACTION PIN LXH TEDAN SURGICAL INNOVATIONS, LLC * W07F2208

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR