BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4909929 · Received December 2, 2014

    Report

    Report Number
    4909929
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    November 26, 2014
    Report Date
    December 2, 2014
    Manufacturer
    LIFE INSTRUMENT CORP.
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DURING A L5 S1 LAMINECTOMY DISCECTOMY, A PITUITARY WAS HANDED TO DR. HE ATTEMPTED TO OPEN THE INSTRUMENT WHILE ADVANCING INTO THE BACK, AND FOUND THAT IT WOULD NOT OPEN, HE THEN HANDED IT OFF AS BROKEN. THE INSTRUMENT WAS LOOKED AT, AND IT APPEARED BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779301 * RONGEUR HTX LIFE INSTRUMENT CORP. 832-0715-0 *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR