BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE PLANNER; SIGNATURE GUIDES

    MDR report key: 3111261 · Received May 8, 2013

    Report

    Report Number
    3003998208-2013-00005
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MATERIALISE N.V.
    Product Code
    JWH
    PMA / PMN Number
    K102795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION IS IN PROGRESS WHICH HAS NOT YET RESULTED IN A ROOT CAUSE FOR THE EVENT. AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED AS SOON AS THE INVESTIGATION IS TERMINATED.

    Description of Event or Problem · 1

    THE PT UNDERWENT A TOTAL KNEE REPLACEMENT GUIDED BY THE DEVICE. THE RESULTING FEMORAL ANGLES DID NOT ALLOW FLEXION WITHOUT SUBLUXATION. THE PHYSICIAN MADE NEW CUTS WHICH RESULTED IN A DELAY OF TWO HOURS. NO OTHER INJURY OR SIGNIFICANT BLOOD LOSS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202431 SIGNATURE PLANNER; SIGNATURE GUIDES JWH MATERIALISE N.V. 42-422461 72108

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other