BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJ. X-CONN. MEDIUM 45-60.5MM

    MDR report key: 2445325 · Received January 27, 2012

    Report

    Report Number
    3008657535-2012-00011
    Event Type
    Malfunction
    Date Received
    January 27, 2012
    Date of Event
    January 12, 2012
    Report Date
    January 27, 2012
    Manufacturer
    THEKEN SPINE LLC
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED INT HE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS EBEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTED STATED THAT DURING A SPINAL SURGERY PROCEDURE, THE DEVICE BROKE AS THE SURGEON TRIED TO LOCK THE CROSS CONNECTOR INTO POSITION. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A SPARE IMPLANT THAT WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1