BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOMA CRX

    MDR report key: 4273500 · Received September 18, 2014

    Report

    Report Number
    3007038372-2014-00006
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    September 8, 2014
    Report Date
    October 9, 2014
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS INC.
    Product Code
    HSB
    PMA / PMN Number
    K092110
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S X-RAYS CONFIRMED THAT THE DEVICE WAS BROKEN AND XRAYS SHOW THAT THE CRX WAS NOT PLACED ACCORDING TO THE IFU AND SURGICAL TECHNIQUE GUIDE. BREAKAGE WAS CAUSED BY THE WAVIBODY BEING TOO CLOSE TO THE FRACTURE SITE. SONOMA'S SURGICAL TECHNIQUE GUIDE CLEARLY SPECIFIES THE MINIMUM IMPLANT DEPTH TO ENSURE ADEQUATE FRACTURE SUPPORT. AT AN UNKNOWN POINT IN TIME POST IMPLANTATION, PATIENT APPARENTLY DEVELOPED AN INFECTION WHICH WAS SUCCESSFULLY TREATED AND NOT EVIDENT AT THE TIME OF REMOVAL. WHILE SOME HEALING HAD OCCURRED BOTH POSTERIOR AND INFERIOR, THERE WAS BONE VOID SLIGHTLY ANTERIOR AND SUPERIOR. AFTER SUCCESSFUL REMOVAL OF THE CRX, NO FURTHER HARDWARE WAS IMPLANTED.

    Description of Event or Problem · 1

    A SONOMA CRX-CWG WAS REMOVED FROM A (B)(6) FEMALE PATIENT ON (B)(6) 2014. THE PATIENT'S CLAVICLE FRACTURE WENT ONTO A NON-UNION DURING THE 8 MONTH POST IMPLANTATION AND AT SOME POINT THE IMPLANT FAILED. BETWEEN THE IMPLANTATION DATE AND REMOVAL DATE THE PATIENT WAS TREATED FOR A SUSPECTED INFECTION. NO INFECTION WAS PRESENT DURING THE REMOVAL SURGERY. THE DEVICE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578146 SONOMA CRX CRX HSB SONOMA ORTHOPEDIC PRODUCTS INC. CRX-WG2-40100-S CU080713-01

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention