BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPLOX II

    MDR report key: 6722060 · Received July 18, 2017

    Report

    Report Number
    3006082533-2017-00004
    Event Type
    Injury
    Date Received
    July 18, 2017
    Date of Event
    May 16, 2017
    Report Date
    July 18, 2017
    Manufacturer
    CAPTIVA SPINE
    Product Code
    MNH
    PMA / PMN Number
    K160020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CAPTIVA SPINE DISTRIBUTOR REPRESENTATIVE CONTACTED CAPTIVA TO INDICATE THAT A CAPLOX II FINAL TORQUE DRIVER DID NOT HAVE A SOLID CONNECTION BETWEEN THE DISTAL TIP AND SET SCREW. THERE WAS A DURAL TEAR AND MEDICAL INTERVENTION WAS REQUIRED TO REPAIR THE TEAR. THE PROCEDURE WAS COMPLETED AND THERE WERE NO FURTHER ISSUES. THE INSTRUMENT WAS RETURNED AND INSPECTED. IT WAS FOUND TO BE CONFORMING TO SPECIFICATION AND FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502727 CAPLOX II ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION MNH CAPTIVA SPINE 2201-5003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention