BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR HEAD TO HEAD - 48MM

    MDR report key: 2103314 · Received May 17, 2011

    Report

    Report Number
    3008657535-2011-00016
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 17, 2011
    Manufacturer
    INTEGRA, MEDINA
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING AN ANTERIOR CORPECTOMY WITH POSTERIOR FUSION SPINAL SURGERY PROCEDURE, THE SURGEON WAS TIGHTENING THE CROSS CONNECTOR AND THE SMALL TAB BROKE OFF THE CROSS CONNECTOR. THE SURGERY WAS COMPLETED USING A ROD TO ROD CONNECTOR INSTEAD. THIS ADDED ONE MINUTE TO SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONNECTOR HEAD TO HEAD - 48MM ATOLL NKB INTEGRA, MEDINA W14790

    Patients

    Seq Age Sex Outcome Treatment
    1