BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1212344 · Received October 8, 2008

    Report

    Report Number
    1212344
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 7, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN HANDED INSTRUMENT OFF TO SCRUB TECHNICIAN STATING IT WAS BROKEN. WHEN EXAMINED IT WAS NOTED THAT THE SCREW WAS FOUND TO BE MISSING. PHYSICIAN NOTIFIED, X-RAY TAKEN, AND REPORTED AS NEGATIVE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * RONGUER, PITUITARY HTX INTEGRA LIFESCIENCES CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR