BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTERYX

    MDR report key: 1565673 · Received December 23, 2009

    Report

    Report Number
    3004719693-2009-00005
    Event Type
    Injury
    Date Received
    December 23, 2009
    Date of Event
    December 7, 2009
    Report Date
    December 23, 2009
    Manufacturer
    INNOVASIS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K061147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ORIGINAL REPORT FROM DISTRIBUTOR: TWO SCREWS BACKED OUT AFTER IMPLANT. DOCTOR IS AFRAID OF ESOPHAGEAL TEAR IF LEFT IN. REPLY WAS MADE TO REP AS FOLLOWS: MAY BE DUE TO ANGULATION OF SCREW. SURGICAL TECHNIQUE GUIDE LCP02 C STATES THE FOLLOWING: " ! PLACING THE SCREW AT AN ANGLE >20 DEGREES MAY RESULT IN FAILURE OF THE SNAP RING TO CAPTURE THE SCREW." REPORTER REPLIED IN 2009, "I SAW THE X-RAYS AND THE SCREWS LOOK PRETTY CLOSE TO 90 DEGREES TO PLATE TO ME, I WILL FORWARD A COPY OF THE X-RAY FOR YOURSELF, AND WHOEVER ELSE." REVISION SURGERY WAS PERFORMED AND THE FOLLOWING WAS NOTED: REVISION SURGERY WAS PERFORMED ONE WEEK LATER. DOCTOR THINKS HE ORIGINALLY PUT THE SCREWS IN AT AN ANGLE EXCEEDING 20 DEGREES. THE FOLLOWING DAY, NOTE: SURGEON USED THE PLATE DURING REVISION SURGERY, HENCE IT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTERYX CERVICAL PLATE KWQ INNOVASIS, INC. 34MM PLATE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention