BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGG/OVAL BUR

    MDR report key: 5002935 · Received August 14, 2015

    Report

    Report Number
    0001811755-2015-02893
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    EJL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT YET RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SHANK OF THE BUR WAS TOO LONG TO USE THE BUR GUARD AND THE BUR SHIELD WAS TOO SHORT. IT WAS FURTHER REPORTED THAT WHEN THE SURGEON SWITCHED BACK TO THE BUR GUARD, PART OF THE SHANK OF THE BUR BURNED THE PATIENTS LIP. IT WAS ALSO REPORTED THAT THERE WAS MEDICAL INTERVENTION TENDING TO BURN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE SHANK OF THE BUR WAS TOO LONG TO USE THE BUR GUARD AND THE BUR SHIELD WAS TOO SHORT. IT WAS FURTHER REPORTED THAT WHEN THE SURGEON SWITCHED BACK TO THE BUR GUARD, PART OF THE SHANK OF THE BUR BURNED THE PATIENTS LIP. IT WAS ALSO REPORTED THAT THERE WAS MEDICAL INTERVENTION TENDING TO BURN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538764 EGG/OVAL BUR BUR, DENTAL EJL STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other