BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLAN CMF

    MDR report key: 18371009 · Received December 21, 2023

    Report

    Report Number
    3005718816-2023-00005
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    December 7, 2023
    Report Date
    December 7, 2023
    Manufacturer
    MATERIALISE USA LLC
    Product Code
    JEY
    UDI-DI
    05420060350016
    PMA / PMN Number
    K103136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KNEE AND FOOT MARKER WERE POSITIONED INCORRECTLY ON THE FIBULA GUIDE.

    Additional Manufacturer Narrative · 0

    SECTION D4 - SERIAL NUMBER HAS BEEN DELETED AS IT IS NOT PRESENT IN THE LABEL - UDI RELATED DATA QUALITY UPDATES ONLY SECTION G6 - TYPE OF REPORT CHANGED FROM "INITIAL" TO "FOLLOW-UP #: 1".

    Description of Event or Problem · 0

    KNEE AND FOOT MARKINGS ON FIBULA GUIDE WERE REVERSED. NO INJURY OR NEED FOR REVISION SURGERY.

    Description of Event or Problem · 0

    KNEE AND FOOT MARKINGS ON FIBULA GUIDE WERE REVERSED. NO INJURY OR NEED FOR REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051815 PROPLAN CMF PATIENT SPECIFIC GUIDE, BONE GRAFT HARVESTING JEY MATERIALISE USA LLC SD900.001 MU23RUKGEQ 05420060350016

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other