BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTRA

    MDR report key: 21655111 · Received March 20, 2025

    Report

    Report Number
    3009540749-2025-00002
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Manufacturer
    MEDARTIS INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS OBTAINED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    ONE PATIENT. ONE HAMMER TOE PROCEDURE. INSERTED PROXIMAL IMPLANT. INSERTED 4.5MM MIDDLE IMPLANT. REDUCED TOE AND CONFIRMED IMPLANTS WERE FULLY COUPLED. UPON LIGHT DISTRCTION IMPLANTS BECAME DECOUPLED. REPLACED PROXIMAL IMPLANT. TRIED AGAIN, SAME PROBLEM. REPLACED MIDDLE IMPLANT WITHA 5.5MM, SAME ISSUE. 2EA NEXTRA PROXIMAL IMPLANTS FROM THE SAME BACTH FAILED TO HOLD ONCE THEY ARE CORRECTLY COUPLED WITH MIDDLE PHALANX IMPLANTS. FAULTY RELOCK MECHANISM IN THIS BATCH. CARE WAS TAKEN TO ENSURE ORIENTATION AND PROPER INSERTION. IMPLANTS WERE AVAILABLE FOR INSPECTION BY REP AFTER BEING REMOVED CONFIRMING FAULT. SEE VIDEO WHICH CONFIMRS THEY ARE BOTH FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451604 NEXTRA NEXTRA HWC MEDARTIS INC. NX-32K-SC 168107824C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown