BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL IMPLANT, SMALL, LEFT

    MDR report key: 1576658 · Received January 11, 2010

    Report

    Report Number
    3004608878-2010-00001
    Event Type
    Injury
    Date Received
    January 11, 2010
    Date of Event
    December 29, 2009
    Report Date
    January 11, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION (INTEGRA OHIO)
    Product Code
    KWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTED STATED THAT DURING A TOTAL WRIST IMPLANT PROCEDURE, THE PT'S RADIUS WAS REAMED READY TO ACCEPT THE RADIAL IMPLANT. WHEN THE SURGEON WAS SEATING PROSTHESIS INTO THE RADIUS, THE PT'S RADIUS FRACTURED AT THE TIP. THE RADIAL PROSTHESIS WAS REMOVED, AND A BURR WAS USED TO REAM OUT THE RADIAL CORTEX TO A LARGER SIZE. THE FRACTURE AROUND THE STEM OF THE PROSTHESIS WAS STABILIZED WITH A 2.7 DCP (DYNAMIC COMPRESSION PLATE); IT IS EXPECTED TO HEAL WELL. THE SURGEON STATED THAT THE DEVICE'S INSTRUCTION FOR USE OUGHT TO REFLECT THAT THE ACTUAL IMPLANT IS 2MM WIDER THAN THE TRIAL. THE SURGICAL PROCEDURE TOOK ABOUT ONE HOUR LONGER THAN IT WOULD IF THE RADIUS FRACTURE HAD NOT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL IMPLANT, SMALL, LEFT UNI2 TOTAL WRIST IMPLANT SYSTEM KWM INTEGRA LIFESCIENCES CORPORATION (INTEGRA OHIO) 1004532L10570

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention