BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRX

    MDR report key: 3092384 · Received April 30, 2013

    Report

    Report Number
    3007038372-2013-00016
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    July 3, 2012
    Report Date
    March 29, 2013
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS INC.
    Product Code
    HSB
    PMA / PMN Number
    K092110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING CLEARLY INDICATES THAT THE DEVICE MUST BE PLACED SUCH THAT THE MEDIAL SEGMENT IS PREPARED 50MM PAST THE MOST MEDIAL EDGE OF THE FRACTURE. IN THIS CASE, THE DEVICE WAS IMPROPERLY PLACED BECAUSE OF USER ERROR. ADEQUATE INSTRUCTIONS DESCRIBE THE PLACEMENT OF THE DEVICE IN THE SURGICAL TECHNIQUE AND THE CONSEQUENCES IF THE DEVICE IS IMPROPERLY PLACED. THERE WAS INFORMATION THE PT WAS NON-COMPLIANT IMMEDIATELY POST-OP. THE SONOMA ORTHOPEDICS CRX IFU CONTRAINDICATED AGAINST "PTS WITH A HIGH LEVEL OF ACTIVITY, WHO ARE NOT WILLING TO MODIFY ACTIVITY LEVEL, IF NEEDED, TO COMPLY WITH POST-OPERATIVE REHABILITATION." IT ALSO WARNS, "IT IS IMPORTANT THAT IMMOBILIZATION OF THE FRACTURE SITE BE MAINTAINED UNTIL FIRM BONY UNION (CONFIRMED BY CLINICAL AND RADIOGRAPHIC EXAM) IS ESTABLISHED," AND THAT, "THE PT MUST BE WARNED THAT NONCOMPLIANCE WITH POST-OPERATIVE INSTRUCTION COULD LEAD TO LOOSENING OR BREAKAGE OF THE IMPLANT AND/OR POSSIBLY MIGRATION, REQUIRING REVISIONAL SURGERY."

    Description of Event or Problem · 1

    THE IMPLANT SURGERY WAS PERFORMED ON (B)(6) 2012 BY A DIFFERENT SURGEON THAN THE ONE THAT REMOVED THE DEVICE. IN THE ORIGINAL SURGERY THE DEVICE WAS NOT PROPERLY PLACED DUE TO USER ERROR. THE PT ORIGINALLY BROKE THEIR CLAVICLE SNOWBOARDING. THE RECORDS INDICATE THAT THE PT PROBABLY FELL IMMEDIATELY POSTOPERATIVELY SNOWBOARDING AND BROKE THE DEVICE. ON (B)(6) 2012 X-RAYS INDICATED THAT THE DEVICE HAD FRACTURED. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2012. THE FRACTURE WAS RESOLVED WITH A PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187341 CRX CRX-WG2 HSB SONOMA ORTHOPEDIC PRODUCTS INC. CRX-WG2-40110 CU140911-01

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention