BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2607415 · Received June 4, 2012

    Report

    Report Number
    3004608878-2012-00115
    Event Type
    Injury
    Date Received
    June 4, 2012
    Report Date
    June 4, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    KWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    DOCTOR REPORTED, "PATIENT WITH A UNIVERSAL2 TOTAL WRIST IMPLANT SHOWED SIGNS OF OSTEOLYSIS." ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE KWM INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1