BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_INSTRUMENTSTIRE_PRODUCT

    MDR report key: 3624324 · Received February 12, 2014

    Report

    Report Number
    0001811755-2014-00455
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 17, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BUR SHATTERED INTRAOPERATIVELY DURING A FACIAL OSTEOTOMY. IT WAS REPORTED THAT THIS WAS ONE OF 3 BURS USED DURING THIS PROCEDURE. NO MEDICAL INTERVENTION, ADVERSE CONSEQUENCES OR SURGICAL DELAY AS A RESULT OF THIS EVENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92734 UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNKNOWN GFF STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown