BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOMA CRX

    MDR report key: 3092389 · Received April 30, 2013

    Report

    Report Number
    3007038372-2013-00008
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    June 29, 2011
    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

    X-RAYS CONFIRMED THE DEVICE WAS NOT IMPLANTED DEEPLY ENOUGH IN THE MEDIAL SEGMENT, PAST THE MOST MEDIAL EDGE OF THE FRACTURE. THE SURGEON DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THE PT WAS NON-COMPLIANT TO POST SURGICAL INSTRUCTIONS FOR LIMITED RANGE OF MOTION AND ACTIVITY.

    Description of Event or Problem · 1

    THE SURGEON REMOVED A SONOMA CRX BECAUSE THE DEVICE WAS BROKEN. THE SURGEON STATED THE PT WAS NON-COMPLIANT TO POST SURGICAL INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188132 SONOMA CRX NONE HSB SONOMA ORTHOPEDIC PRODUCTS INC. CRX-WG2-4090 CU170810-02

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention