BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONOMA CRX

    MDR report key: 3092479 · Received April 30, 2013

    Report

    Report Number
    3007038372-2013-00005
    Event Type
    Other
    Date Received
    April 30, 2013
    Date of Event
    March 3, 2011
    Report Date
    March 29, 2013
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS, INC
    Product Code
    HSB
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON USED THE SONMA CRX-WG2 ON A PT THAT WAS NOT SKELETALLY MATURE. ACTIVE BONE GROWTH IN YOUNG PTS CAN LEAD TO ENCASEMENT AND ENTRAPMENT OF THE DEVICE. IN THESE SITUATIONS, ADDITIONAL STEPS CAN BE TAKEN TO REMOVE THE REMAINING PIECE OF THE IMPLANT. THE SURGEON DECIDED NOT TO DO SO. THE USE OF THIS PRODUCT ON SKELETALLY IMMATURE PTS IS A CONTRAINDICATION.

    Description of Event or Problem · 1

    A YOUNG MALE PT WAS IMPLANTED WITH A SONOMA CLAVICLE PIN FOR THE TREATMENT OF A FRACTURED CLAVICLE ON (B)(6) 2010. THE FRACTURE HAD HEALED. THE SURGEON ELECTED TO REMOVE THE IMPLANT ON (B)(6) 2011. DURING REMOVAL THE IMPLANT BROKE. THE PT WAS SKELETALLY IMMATURE WITH ACTIVE BONE GROWTH. THE SURGEON THROUGH BONEY IN-GROWTH LED TO DIFFICULTY TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186474 SONOMA CRX CRX HSB SONOMA ORTHOPEDIC PRODUCTS, INC CRX-WG2-40120 CU100910-08

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention