BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN

    MDR report key: 1151943 · Received September 5, 2008

    Report

    Report Number
    MW5008213
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 29, 2008
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN O.R. FOR LEFT L4-5 EXPLORATION, LAMINOTOMY AND POSSIBLE DISECTOMY. DURING COURSE OF DISECTOMY, THE CROSS HINGE PIN FROM A SMALL PITUITARY RONGEUR DISENGAGED FROM THE INSTRUMENT. SEARCH FOR PIN INITIATED, HOWEVER, COULD NOT BE IDENTIFIED. X-RAY TAKEN, PIN LOCATED. HOWEVER, NOT PALPABLE OR VISIBLE. GIVEN THE MINUTE SIZE, IT WAS DECIDED TO LEAVE IT IN. PT NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN PITUITARY RONGEUR HTX CODMAN 29

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other