BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPAL POLY MEDIUM - STD

    MDR report key: 3052952 · Received April 5, 2013

    Report

    Report Number
    3004608878-2013-00060
    Event Type
    Injury
    Date Received
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    KWN
    PMA / PMN Number
    K030037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE SURGEON GAVE INTEGRA REPS AN EXPLANTED UNIVERSAL 2 TOTAL WRIST CARPAL POLY (STANDARD MEDIUM SIZE) DURING A MEETING AS AN EXAMPLE OF POLY WEAR. THE PART SHOWED DELAMINATION AND WEAR OF THE ARTICULAR SURFACE. THERE WAS PATIENT CONTACT AND REVISION WAS REQUIRED. ADD'L INFO WAS REQUESTED BUT AS PER SURGEON, HE DID NOT HAVE ANY OF THE REQUESTED INFO AND THERE WAS NO WAY FOR HIM TO FIND IT AS HE NOW KNOWS THAT THIS PARTICULAR IMPLANT WAS SENT TO HIM BY ANOTHER SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141698 CARPAL POLY MEDIUM - STD UNI2 TOTAL WRIST IMPLANT SYSTEM KWN INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention