BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL IMPLANT X-SMALL LEFT

    MDR report key: 2489413 · Received March 8, 2012

    Report

    Report Number
    3004608878-2012-00054
    Event Type
    Injury
    Date Received
    March 8, 2012
    Date of Event
    February 9, 2012
    Report Date
    March 8, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    JWJ
    PMA / PMN Number
    K030037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO. THIS PT EVENT IS ALSO REPORTED IN MFR REPORT NUMBERS 3004608878-2012-00052 AND 3004608878-2012-00048.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE IMPLANTED DEVICES WAS REMOVED DURING REVISION SURGERY. IT HAD BEEN IMPLANTED ABOUT FIVE YEARS AGO. ON INITIAL EXPOSURE OF THE WOUND, THE SURGEON NOTICED BLACK DEBRIS. THE IMPLANT WAS REMOVED, THE WOUND IRRIGATED AND CLOSED WITH NO REPLACEMENT. THE PRECISE PRODUCT CATALOGUE NUMBER WAS NOT PROVIDED. INTEGRA HAS REQUESTED ADD'L CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL IMPLANT X-SMALL LEFT UNI2 TOTAL WRIST IMPLANT SYSTEM JWJ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention