BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL SMALL, RIGHT

    MDR report key: 1051684 · Received May 19, 2008

    Report

    Report Number
    3004608878-2008-00022
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    February 20, 2008
    Report Date
    May 19, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    KWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IN A VOLUNTARY MEDWATCH RECEIVED FROM NORTHERN MICHIGAN REGIONAL HOSPITAL, THE REPORTER STATED THAT THE TOTAL WRIST IMPLANT FRACTURED AND REQUIRED REPAIR. THE PATIENT NEEDED A SURGICAL PROCEDURE DURING WHICH THE DAMAGED IMPLANT WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE TO CONTACT THE SURGEON BY TELEPHONE AND IN WRITING. NO ADDITIONAL INFORMATION IS AVAILABLE TO DATE. PLEASE SEE ALSO MFR REPORT NUMBER 3004608878-2008-00024 FOR THE OTHER WRIST IMPLANT COMPONENT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL SMALL, RIGHT TOTAL WRIST IMPLANT KWM INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Congenital Anomaly| R