BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRX

    MDR report key: 2935404 · Received January 24, 2013

    Report

    Report Number
    3007038372-2013-00001
    Event Type
    Other
    Date Received
    January 24, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON USED THE SONOMA CRX-CWG OFF LABEL. THE SONOMA CRX-CWG IS CONTRAINDICATED AS STATED IN THE INSTRUCTIONS FOR USE - FOR PATIENTS WITH SKELETAL IMMATURITY.

    Description of Event or Problem · 1

    A YOUNG MALE PATIENT WAS IMPLANTED WITH A SONOMA CLAVICLE PIN FOR THE TREATMENT OF A FRACTURE CLAVICLE ON (B)(6) 2012. THE FRACTURE HEALED. THE SURGEON ELECTED TO REMOVE THE IMPLANT ON (B)(6) 2012. WHILE REMOVING THE IMPLANT BY USING A SLAP HAMMER TO FREE IT FROM THE INTRAMEDULLARY CANAL, THE IMPLANT BROKE. THE LATERAL HUB WAS REMOVED AND THE SURGEON LEFT A PORTION OF THE IMPLANT IN THE BONE. ON (B)(6) 2013, THE SURGEON USED SONOMA'S ADVANCED REMOVAL TOOL SET TO ATTEMPT TO REMOVE THE REMAINING PORTION OF THE IMPLANT. THE SHAFT WAS SUCCESSFULLY REMOVED, HOWEVER, THE LATERAL TIP BROKE FROM THE SHAFT AND WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34580 CRX CRX-CWG HSB SONOMA ORTHOPEDIC PRODUCTS CRX-CWG CU310511-04

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention