BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXBRIDGE ANKLE FUSION NAIL 11MM X 250MM (TI6AL4V)

    MDR report key: 21643938 · Received March 19, 2025

    Report

    Report Number
    3008951116-2025-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 14, 2025
    Report Date
    April 16, 2025
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HSB
    PMA / PMN Number
    K121575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE OXBRIDGE NAIL WAS USED IN A MESHWORKS 3D PRINTED FUSION CAGE SURGERY. THE NAIL FRACTURED INTO TWO PIECES AROUND 2 YEARS AFTER THE DEVICE WAS IMPLANTED. THE PATIENT HAS HAD FURTHER SURGERY TO REMOVE THE BROKEN NAIL AND TO REPLACE IT WITH A DIFFERENT ONE.

    Description of Event or Problem · 0

    THE OXBRIDGE NAIL WAS USED IN A MESHWORKS 3D PRINTED FUSION CAGE SURGERY. THE NAIL FRACTURED INTO TWO PIECES AROUND 2 YEARS AFTER THE DEVICE WAS IMPLANTED. THE PATIENT HAS HAD FURTHER SURGERY TO REMOVE THE BROKEN NAIL AND TO REPLACE IT WITH A DIFFERENT ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453385 OXBRIDGE ANKLE FUSION NAIL 11MM X 250MM (TI6AL4V) INTRAMEDULLARY NAIL HSB ORTHO SOLUTIONS UK LTD OS331125N 2021002676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown