BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOMA WRX

    MDR report key: 3092362 · Received April 30, 2013

    Report

    Report Number
    3007038372-2013-00013
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 4, 2012
    Report Date
    January 31, 2013
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SALES REP INDICATED THAT THE DEVICE WAS PLACED TOO PROXIMAL AND THAT THE FRACTURE SUBSIDED. THE PRODUCT LITERATURE AND INSTRUCTIONS FOR USE ADEQUATELY ADDRESS THIS ISSUE. THE DEVICE WAS REMOVED AND REPLACED WITH A PLATE 3 WEEKS AFTER ORIGINAL SURGERY. THE FRACTURE SUBSIDED BECAUSE THE IMPLANT WAS NOT PROPERLY PLACED DUE TO USER ERROR.

    Description of Event or Problem · 1

    A SONOMA WRX DISTAL FIXATION DEVICE WAS REMOVED APPROX 3 WEEKS AFTER IT WAS IMPLANTED. THE DISTRIBUTOR REP STATED THAT THE DEVICE WAS PLACED TOO PROXIMAL AND THE FRACTURE SUBSIDED. THE DEVICE WAS NOT RETURNED AND NO SURGICAL DATA (X-RAYS, PT INFORMATION, OR OPERATIVE NOTES) WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188165 SONOMA WRX SRX HRS SONOMA ORTHOPEDIC PRODUCTS INC. WRX5470 CU060312-01

    Patients

    Seq Age Sex Outcome Treatment
    1