BEUDAMED
    FDA Adverse Event Death Summary report: N

    EGG/OVAL BUR

    MDR report key: 2713664 · Received August 21, 2012

    Report

    Report Number
    9616696-2012-00229
    Event Type
    Death
    Date Received
    August 21, 2012
    Date of Event
    August 7, 2012
    Report Date
    August 9, 2012
    Manufacturer
    STRYKER IRELAND LTD
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED TO THE MFR FOR EVAL, IF THE BUR IS RECEIVED, AN EVAL WILL BE PERFORMED AND A F/U MDR WILL BE SUBMITTED. LOT NUMBER INFO HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE CUSTOMER THAT DURING A NASAL AIRWAY EXPANSION PROCEDURE, A 4MM BUR WAS USED ON THE LONG STEM. IT WAS ALSO REPORTED THAT WHEN THE 4 MM BUR BECAME DULL, IT WAS REMOVED AND EXCHANGED FOR A NEW BUR. A SECOND BUR WAS THEN USED TO FURTHER BURR DOWN THE SEPTUM AGAINST THE THICKENED HYPERTROPHIED BONE IN THE NASAL CAVITY. DURING THIS PROCESS, IT WAS REPORTED THAT THE HEAD OF THE BUR BROKE AND WAS FOUND LOOSE AND FLOATING AT THE BASE OF THE SINUS. IT WAS FURTHER REPORTED THAT A THIRD BUR WAS USED FOR APPROXIMATELY 15 TO 30 MINUTES AT A DRILL DEPTH OF 5.5 TO 6 CMS; AN ACUTE HAEMORRHAGE BECAME APPARENT AT THIS POINT AND WAS FOUND TO BE FROM AN INTERNAL CAROTID ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGG/OVAL BUR EQJ STRYKER IRELAND LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death