BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE PLANNER; SIGNATURE GUIDES

    MDR report key: 3144723 · Received May 31, 2013

    Report

    Report Number
    3003998208-2013-00006
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    August 30, 2012
    Report Date
    April 9, 2013
    Manufacturer
    MATERIALISE N.V.
    Product Code
    JWH
    PMA / PMN Number
    K102795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE PROVIDED AS SOON AS THE INVESTIGATION IS CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012, GUIDED BY THE DEVICE. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2013, DUE TO PATIENT KNEE WAS IN VALGUS. THE BEARING AND TRAY WAS REMOVED AND REPLACED. THE REPORTER REPORTED THE FIT OF THE PATIENT SPECIFIC DEVICE WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240517 SIGNATURE PLANNER; SIGNATURE GUIDES JWH MATERIALISE N.V. 42-422561 56105

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention