BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOMA CRX

    MDR report key: 3092373 · Received April 30, 2013

    Report

    Report Number
    3007038372-2013-00010
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    August 31, 2011
    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 MEDIAL SEGMENT WAS NOT PREPARED TO THE REQUISITE DEPTH PER THE SURGICAL TECHNIQUE GUIDE AND IFU. THE DEVICE WAS IMPROPERLY PLACED. BREAKAGE WAS CAUSED BY THE WAVIBODY BEING TOO CLOSE TO THE FRACTURE SITE. THE SURGEON DID NOT FOLLOW THE INSTRUCTION FOR USE SUCH THAT THE IMPLANT FAILED.

    Description of Event or Problem · 1

    A SONOMA CRX-CWG WAS REMOVED FROM A PT 2 MONTHS AFTER THE DATE IT WAS IMPLANTED BECAUSE THE HARDWARE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188020 SONOMA CRX CRX HSB SONOMA ORTHOPEDIC PRODUCTS INC. CRX-CWG-40100 CU010611-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention