BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATOR

    MDR report key: 2170645 · Received July 18, 2011

    Report

    Report Number
    MW5021378
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 30, 2011
    Manufacturer
    CONMED LINVATEC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LINVATEC ONE TIME USE SHAVERS LEAVING SMALL AMOUNT OF METAL SHAVINGS IN SHOULDER JOINT MANAGER NOTIFIED JOINT FLUSHED OUT WITH (B)(6). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATOR SHAVER HRX CONMED LINVATEC
    2 OVAL BUR SHAVER HRX CONMED LINVATEC

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR