BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FULL RADIUS RESECTOR

    MDR report key: 1840188 · Received September 14, 2010

    Report

    Report Number
    MW5017449
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 14, 2010
    Manufacturer
    CONMED LINVATEC CORP.
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARTHROSCOPY OF SHOULDER WITH ROTATOR CUFF REPAIR. METAL SHAVINGS NOTED IN THE SURGICAL FIELD AFTER USING THE LINVATEC FULL RADIUS RESECTOR. DIAGNOSIS OR REASON FOR USE: ROTATOR CUFF REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL RADIUS RESECTOR FULL RADIUS RESECTOR HRX CONMED LINVATEC CORP. 160334, 062310

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR