BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOMA CRX

    MDR report key: 3092372 · Received April 30, 2013

    Report

    Report Number
    3007038372-2013-00011
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    February 20, 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 "NON-UNION" OCCURRED DUE TO FAILURE TO PROPERLY REDUCE FX DURING THE INITIAL PROCEDURE. THE IFU AND SURGICAL TECHNIQUE GUIDE PROVIDE WARNINGS/ PRECAUTIONS ABOUT NON-UNIONS AND INSTRUCTION ON FRACTURE REDUCTION. IF BONE FRAGMENTS ARE NOT PROPERLY POSITIONED AROUND THE IMPLANT THERE IS A PROBABILITY BONY UNION WILL NOT OCCUR. THIS PROBLEM OCCURRED DUE TO SURGICAL ERROR.

    Description of Event or Problem · 1

    A SONOMA CRX CLAVICLE FIXATION DEVICE WAS REMOVED APPROXIMATELY 3 MONTHS AFTER INITIAL SURGERY FOR A NON-UNION. THE IMPLANT WAS INTACT UPON REMOVAL. THE FRACTURE WAS POORLY REDUCED AND A GAP WAS LEFT BETWEEN THE MEDIAL AND LATERAL SEGMENTS. THE DEVICE WAS NOT RETURNED AND NO SURGICAL DATA (X-RAY, PT INFO, OR OPERATIVE NOTES) WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187339 SONOMA CRX CRX HSB SONOMA ORTHOPEDIC PRODUCTS INC. CRX-WG2-40110 CU070611-04

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention