BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOMA CRX

    MDR report key: 3092378 · Received April 30, 2013

    Report

    Report Number
    3007038372-2013-00019
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    October 8, 2012
    Report Date
    January 31, 2013
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LATERAL LOCKING CROSS SCREW WAS REMOVED BEFORE ACHIEVING BONY UNION. THE SURGEON FAILED TO REPLACE THE SCREW. THE CROSS SCREW IS A KEY ELEMENT IN THE FRACTURE FIXATION, AND THEREFORE, IT IS REASONABLE TO CONCLUDE THAT USER ERROR LED TO THE NON-UNION. THE IFU STATES THAT THE CROSS SCREW MUST BE PLACED TO SECURE THE IMPLANT.

    Description of Event or Problem · 1

    A SONOMA CRX WAS IMPLANTED ON (B)(6) 2012. THE LATERAL CROSS SCREW STARTED TO BACK OUT 1 MONTH POST OP AND THE SURGEON REMOVED THE CROSS SCREW IN HIS OFFICE. THE PT WENT TO A NON-UNION. THE IMPLANT WAS REMOVED ON (B)(6) 2012. THE PT WAS REVISED WITH A PLATE AND BONE GRAFT. THE REMOVAL WAS UNEVENTFUL AND THE HARDWARE WAS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187340 SONOMA CRX CRX HSB SONOMA ORTHOPEDIC PRODUCTS INC. CRX-WG2-40130 CU280911-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention