BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADJ X-CONN. MEDIUM 45-60.5MM

    MDR report key: 1784291 · Received July 28, 2010

    Report

    Report Number
    1530901-2010-00058
    Event Type
    Other
    Date Received
    July 28, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 28, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A PT REQUIRED REVISION SURGERY BECAUSE OF AN APPARENT DURAL TEAR. IT WAS OBSERVED THAT THE TEAR OCCURRED AT THE SAME LOCATION THE GREY CENTER BAR WAS AT ON THE LARGE ADJUSTABLE CONNECTOR. THE SURGEON REPORTED THAT THE CROSS CONNECTORS CANNOT BE ARCHED AND THAT THEY MAY AGAINST THE DURA MATER. INTEGRA HAS REQUESTED ADDITIONAL INFO FROM THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJ X-CONN. MEDIUM 45-60.5MM CORAL KWP THEKEN SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention