BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET

    MDR report key: 5056866 · Received September 2, 2015

    Report

    Report Number
    9614209-2015-00052
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    August 19, 2015
    Report Date
    September 2, 2015
    Manufacturer
    CORIN, LTD.
    Product Code
    KWL
    PMA / PMN Number
    K111911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. DEVICE DETAILS, PATIENT MEDICAL HISTORY, POST PRIMARY AND PRE-REVISION X-RAYS AND EXPLANT HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MANUFACTURING RECORDS WILL BE REVIEWED.

    Description of Event or Problem · 1

    REVISION OF CORMET OPTIMOM HEAD AFTER 6 YEARS, 6 MONTHS, DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583143 CORMET MODULAR HEAD KWL CORIN, LTD. E479.746 217023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention