BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOMA CRX

    MDR report key: 3092388 · Received April 30, 2013

    Report

    Report Number
    3007038372-2013-00007
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 7, 2011
    Report Date
    January 31, 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 SONOMA IFU STATES, "COMPLICATIONS AND ADVERSE EFFECTS: NONUNION OR DELAYED UNION OF THE FRACTURE WHICH CAN LEAD TO BREAKAGE OF THE IMPLANT, OR BENDING, BREAKAGE OR SEPARATION OF THE METAL COMPONENTS DUE TO OTHER CAUSES." THE PT ORIGINALLY PRESENTED WITH A MAL-UNION. IT IS UNCLEAR WHETHER THE SONOMA CRX CAUSED OR CONTRIBUTED TO THE SUBSEQUENT BROKEN HARDWARE AND NON-UNION WHICH LED TO THE NEED FOR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    A (B)(6) MALE PRESENTED WITH A MALUNION. THE ORIGINAL SURGERY WAS A MALUNION TAKEDOWN AND ORIF, WITH A SONOMA CRX-WG2-40120. THE SURGEON ELECTED TO DO A DOUBLE OSTEOTOMY AND CREATED A SEGMENTAL FRACTURE. THE PT CAME BACK 5 MONTHS POST-OP WITH A NON-UNION AND BROKEN IMPLANT AT THE WAVIBODY ON (B)(6) 2011, THE DOCTOR REMOVED THE BROKEN CRX AND FOUND A 1CM GAP AT THE NONUNION SITE. THE PT WAS REVISED WITH SONOMA COMPRESSION IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187464 SONOMA CRX CRX HSB SONOMA ORTHOPEDIC PRODUCTS INC. CRX-WG2-40120 CU100910-08

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention