BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTRA CH

    MDR report key: 21594660 · Received March 13, 2025

    Report

    Report Number
    3009540749-2025-00001
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    June 26, 2024
    Report Date
    October 30, 2025
    Manufacturer
    MEDARTIS INC.
    Product Code
    HWC
    UDI-DI
    00817701026310
    PMA / PMN Number
    K221610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CLOSED. THERE IS NO CHANGE TO THE OUTCOME OF THE INVESTIGATION. ADDITIONAL FIELDS WERE COMPLETED WITH KNOWN INFORMATION NOT PREVIOUSLY INCLUDED.

    Description of Event or Problem · 0

    WE USED NEXTRA CH IMPLANT AND THE PROXIMAL AND MIDDLE IMPLANTS DID NOT FIT PROPERLY WITHIN EACH OTHER. THE IMPLANTS WERE SLIPPING OUT OF EACH OTHER EVERY TIME HE TRIED TO CLOSE. PROBLEM STATEMENT: IMPLANTS WOULD NOT LOCK.

    Description of Event or Problem · 0

    WE USED NEXTRA CH IMPLANT AND THE PROXIMAL AND MIDDLE IMPLANTS DID NOT FIT PROPERLY WITHIN EACH OTHER. THE IMPLANTS WERE SLIPPING OUT OF EACH OTHER EVERY TIME HE TRIED TO CLOSE. PROBLEM STATEMENT: IMPLANTS WOULD NOT LOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521896 NEXTRA CH NEXTRA CH HWC MEDARTIS INC. CH-35M, CH-M35M, CH-32P-KT 1574804, 1574809, 168101 00817701026310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown