BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJ. X.CONN.SMALL 40-50MM

    MDR report key: 2180797 · Received July 7, 2011

    Report

    Report Number
    3008657535-2011-00027
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 7, 2011
    Manufacturer
    INTEGRA, MEDINA
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 THE CORAL CROSSLINK BROKE AS THE SURGEON WAS ATTEMPTING TO PLACE IT DURING A SPINAL SURGERY PROCEDURE. THE CROSSLINK SHEARED AT THE MIDDLE SECTION. THE CROSSLINK WAS REPLACED WITH A NEW ONE. THERE WERE NO PT ADVERSE OUTCOMES REPORTED. THE COMPLAINT SAMPLE WAS NOT RECOVERED FROM THE HOSPITAL AT THIS TIME. INTEGRA HAS REQUESTED ADD'L CLINICAL INFO FROM THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJ. X.CONN.SMALL 40-50MM CORAL KWP INTEGRA, MEDINA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1