BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOMA CRX

    MDR report key: 3092361 · Received April 30, 2013

    Report

    Report Number
    3007038372-2013-00012
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 19, 2012
    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 DEVICE WAS NOT PLACED ACCORDING TO THE IFU. THE FRACTURE PATTERN WAS CONTRAINDICATED. ADDITIONALLY, THE PT WAS BELIEVED TO BE NON-COMPLIANT AS REPORTED BY THE SURGEON THROUGH THE SALES REP. AS SUCH, OFF LABEL USE OF THE DEVICE CREATED A SITUATION WHERE THE IMPLANT WAS USED ON A FRACTURE FOR WHICH IT WAS NOT SUITED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A SONOMZ CRX-CWG WAS REMOVED FROM A PT 3 MONTHS AFTER THE DATE IT WAS IMPLANTED BECAUSE THE HARDWARE WAS BROKEN. THE DEVICE WAS NOT PLACED ACCORDING TO THE IFU. THE FRACTURE TYPE, A LONG OBLIQUE, WAS A CONTRAINDICATION FOR THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188019 SONOMA CRX CRX HSB SONOMA ORTHOPEDIC PRODUCTS INC. CRX-CWG-40100 CU310511-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention