BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR HEAD TO HEAD - 34MM

    MDR report key: 2182590 · Received July 5, 2011

    Report

    Report Number
    3008657535-2011-00023
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    May 30, 2011
    Report Date
    July 5, 2011
    Manufacturer
    INTEGRA, MEDINA
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT AT THE PLACE WHERE THE CROSS CONNECTOR SNAPS DOWN OVER THE TOP OF THE SCREW, THE SIDE PIECE WAS OBSERVED TO BE BROKEN OFF. THE DEVICE WAS NOT PLACED INTO, OR IMPLANTED, INTO THE PT. THE REPORTER STATED THAT IT MAY HAVE BEEN BROKEN IN TRANSIT TO THE DISTRIBUTOR, OR THAT THE BREAKAGE OCCURRED AS IT WAS HANDLED BY OPERATING ROOM STAFF. INTEGRA HAS REQUESTED THE RETURN OF THE DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONNECTOR HEAD TO HEAD - 34MM ATOLL KWP INTEGRA, MEDINA W9940

    Patients

    Seq Age Sex Outcome Treatment
    1