BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGG/OVAL BUR

    MDR report key: 5586425 · Received April 19, 2016

    Report

    Report Number
    0001811755-2016-00387
    Event Type
    Injury
    Date Received
    April 19, 2016
    Date of Event
    March 23, 2016
    Report Date
    July 19, 2017
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE BUR BROKE AND LANDED ON THE BONE OF THE PATIENT. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS REMOVED FROM THE BONE RESULTING IN A DELAY OF GREATER THAN 30 MINUTES. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE BUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE BUR BROKE AND LANDED ON THE BONE OF THE PATIENT. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS REMOVED FROM THE BONE RESULTING IN A DELAY OF GREATER THAN 30 MINUTES. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE BUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241850 EGG/OVAL BUR BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF STRYKER INSTRUMENTS-KALAMAZOO 15357017

    Patients

    Seq Age Sex Outcome Treatment
    1