BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS-CUT FISSURE BUR, LONG TAPERED

    MDR report key: 2102948 · Received May 12, 2011

    Report

    Report Number
    9616696-2011-00076
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 15, 2011
    Manufacturer
    STRYKER INSTRUMENT CORK
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED TO THE MFR FOR EVAL. MFG RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR BROKE WHILE BEING LOADED INTO THE HANDPIECE. IT WAS ALSO REPORTED THAT THERE WAS NO PT INVOLVEMENT. NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSS-CUT FISSURE BUR, LONG TAPERED EQJ STRYKER INSTRUMENT CORK 10260017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK