BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERIOR CERVICAL PLATE 2 LEVEL 31MM

    MDR report key: 2572401 · Received May 8, 2012

    Report

    Report Number
    2032593-2012-00022
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    March 9, 2012
    Report Date
    May 8, 2012
    Manufacturer
    SEASPINE, INC.
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT TWO CERVICAL SCREWS WERE SEEN, ON X-RAYS, TO HAVE BACKED OUT OF THE SONOMA PLATE AT LEVEL C5. THERE WAS NO SIGNIFICANT FAILURE MECHANISM THAT THE PT HAS IDENTIFIED. ALSO IMPLANTED WERE: 39-1507 (2) CAMBRIA IMPLANT 15MM X 13MM X 7MM, LORDOTIC; 23-4014 (4) VARIABLE BONE SCREW, 4.0 X 14MM, 20-4014 (1) LIMITED ANGLE BONE SCREW 4.0 X 14MM; 22-4514 (1) BONE SCREW, LIMITED ANGLE, DOUBLE LEAD, 4.5 X 14MM. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTERIOR CERVICAL PLATE 2 LEVEL 31MM SONOMA JDN SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1