BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICRO BUR, HEAVY GRIT DIAMOND

    MDR report key: 695766 · Received April 3, 2006

    Report

    Report Number
    1017294-2006-00110
    Event Type
    Other
    Date Received
    April 3, 2006
    Date of Event
    October 6, 2005
    Report Date
    March 10, 2006
    Manufacturer
    CONMED LINVATEC CORP.
    Product Code
    GPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT RECEIVED A POST OPERATIVE INFECTION FOLLOWING A CERVICAL LAMINOPLASTY AND THORACIC LAMINECTOMY. THE USER FACILITY REPORTED THAT THE INFECTION MAY BE RELATED TO A MICRO BUR USED IN THIS PROCEDURE. IN ADDITION, THE USER FACILITY REPORTED THAT THE MICRO BUR USED IN THIS SURGERY MAY BE ONE IDENTIFIED IN A RECENT RECALL. THE PT'S WOUND WAS CULTURED AND THE INFECTION WAS IDENTIFIED AS MRSA. PT DISCHARGED FROM HOSP IN 2006 WITH CRUTCH WALKING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO BUR, HEAVY GRIT DIAMOND BUR GPF CONMED LINVATEC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization