BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, 4.5MM X 30MM L

    MDR report key: 2516830 · Received March 30, 2012

    Report

    Report Number
    3004608878-2012-00066
    Event Type
    Injury
    Date Received
    March 30, 2012
    Date of Event
    February 22, 2012
    Report Date
    March 30, 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
    GM
    Reporter Occupation
    OTHER

    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

    THE REPORTER STATED THAT DUE TO AN INCIDENT, A FRACTURE OF THE IMPLANTED TOTAL WRIST IMPLANT SYSTEM CARPAL CARRIER PART AND A SCREW OCCURRED. WE DO NOT KNOW HOW EXACTLY THE INCIDENT OCCURRED. THE PATIENT HAD TO UNDERGO REVISION SURGERY ON (B)(6) 2012. THE CARPAL CARRIER PART, THE POLYETHYLENE PART AND TWO SCREWS WERE REPLACED IN THIS OPERATION. THE RADIUS PART HAS NOT BEEN REPLACED BUT REMAINED IN THE WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW, 4.5MM X 30MM L UNI2 TOTAL WRIST IMPLANT SYSTEM JWJ INTEGRA LIFESCIENCES CORPORATION OH/USA 7840-D

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention