BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEON CRX

    MDR report key: 1942434 · Received December 22, 2010

    Report

    Report Number
    3007038372-2010-00018
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 22, 2010
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS, INC.
    Product Code
    HSB
    PMA / PMN Number
    K081832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS REMOVED ELECTIVELY. NOT MEDICALLY NECESSARY.

    Description of Event or Problem · 1

    DEVICE EXPLANTED WITH WOUND DEBRIDEMENT. PT'S WOUND HAD DEHISCENCE. WOUND CULTURED NEGATIVE FOR INFECTION. PT HAD GOOD RADIOLOGICAL HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVEON CRX CLAVICLE INTRAMEDULLARY BONE FIXATION HSB SONOMA ORTHOPEDIC PRODUCTS, INC. CU100510-01

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR