BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMATCH

    MDR report key: 14216828 · Received April 27, 2022

    Report

    Report Number
    3005718816-2022-00001
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    April 8, 2022
    Report Date
    April 8, 2022
    Manufacturer
    MATERIALISE USA LLC
    Product Code
    JEY
    UDI-DI
    05420060351020
    PMA / PMN Number
    K103136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    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
    970023 TRUMATCH SD900.102 PATIENT SPECIFIC GUIDE, BONE GRAFT HARVESTING JEY MATERIALISE USA LLC SD900.102 MU22LUMCUR 05420060351020

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other