BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTERYX CERVICAL PLATE SYSTEM

    MDR report key: 1908960 · Received November 29, 2010

    Report

    Report Number
    3004719693-2010-00001
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    September 15, 2010
    Report Date
    November 2, 2010
    Manufacturer
    INNOVASIS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K061147
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY--PATIENT DID NOT FUSE. MALE PATIENT IN HIS 70'S--NON-SMOKER. ORIGINAL SURGERY IN (B)(6) 2010 IN (B)(6). REVISION SURGERY (DIFFERENT SURGEON) C5-C7 IN (B)(6) 2010. BOTTOM TWO SCREWS BROKE, CAGES WERE LOOSE, NO FUSION. SURGEON (DR (B)(6)) STATED THAT PROBLEM WAS NOT WITH THE INNOVASIS PRODUCT, BUT WAS CAUSED BY FATIGUE DUE TO NON-FUSION. PATIENT REQUESTED HARDWARE TO TAKE HOME--NOT RETURNED TO INNOVASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTERYX CERVICAL PLATE SYSTEM VARIABLE SCREW 4.0 X 17MM KWQ INNOVASIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention CERVICAL CAGE (2)| OPTERYX CERVICAL PLATE 34MM