BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOMA CRX

    MDR report key: 3092374 · Received April 30, 2013

    Report

    Report Number
    3007038372-2013-00015
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    June 15, 2013
    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 CAUSE OF THE NON-UNION WAS SURGEON ERROR DURING THE INITIAL IMPLANT SURGERY. PROPER REDUCTION OF THE FRACTURE IS NECESSARY. IN THE INITIAL SURGERY, PROPER REDUCTION WAS NOT ACHIEVED ACCORDING TO THE DISTRIBUTORS REP. THE SURGEON ALSO REMOVED THE HARDWARE IN 4.5 MONTHS OR 18 WEEKS. CLAVICLE FRACTURES REQUIRE 12 TO 26 WEEKS TO HEAL. AFTER 26 WEEKS, IF THE FRACTURE HAS NOT HEALED, IT IS A NON-UNION. THIS HARDWARE WAS REMOVED PRIOR TO 6 MONTHS AND MAY BE PREMATURE.

    Description of Event or Problem · 1

    A SONOMA CRX CLAVICLE FIXATION DEVICE WAS REMOVED APPROXIMATELY 4.5 MONTHS AFTER INITIAL SURGERY FOR A NON-UNION. THE DISTRIBUTOR'S REP STATED THAT THE NON-UNION OCCURRED DUE TO FAILURE TO PROPERLY REDUCE THE FRACTURE PRIOR TO CLOSING DURING THE INITIAL PLACEMENT OF THE IMPLANT. NO ADD'L FIXATION OR THERAPY WAS APPLIED TO THE FRACTURE AFTER THE HARDWARE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188190 SONOMA CRX CRX HSB SONOMA ORTHOPEDIC PRODUCTS INC. CRX-WG2-40100 CU270711-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention