BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLATE, CARPAL SMALL

    MDR report key: 1702150 · Received May 27, 2010

    Report

    Report Number
    3004608878-2010-00042
    Event Type
    Other
    Date Received
    May 27, 2010
    Date of Event
    April 14, 2010
    Report Date
    May 27, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION (INTEGRA-OHIO)
    Product Code
    KWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE COMPLAINT SAMPLE HAS NOT BEEN COMPLETED. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PATIENT REPORTED PAIN AT THE SITE OF THE IMPLANT. X-RAYS WERE TAKEN AND IT WAS NOTICED THAT THE IMPLANT WAS BROKEN. THE PATIENT HAD A SURGICAL PROCEDURE TO REMOVE THE IMPLANTED DEVICE. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE, CARPAL SMALL UNI2 TOTAL WRIST IMPLANT SYSTEM KWN INTEGRA LIFESCIENCES CORPORATION (INTEGRA-OHIO) 107035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention