BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FULL RADIUS RESECTOR

    MDR report key: 1840187 · Received September 14, 2010

    Report

    Report Number
    MW5017448
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 14, 2010
    Manufacturer
    CONMED LINVATEC, LINVATEC CORP.
    Product Code
    HWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    METAL SHAVING NOTED IN OPERATIVE KNEE AFTER USING FULL RADIUS RESECTOR. DIAGNOSIS OR REASON FOR USE: DERANGEMENT MEDIAL MENISCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL RADIUS RESECTOR FULL RADIUS RESECTOR HWE CONMED LINVATEC, LINVATEC CORP. 160334, 172201, 65829

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR