BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEX D 2

    MDR report key: 10979968 · Received December 9, 2020

    Report

    Report Number
    3010020754-2020-00001
    Event Type
    Injury
    Date Received
    December 9, 2020
    Date of Event
    September 16, 2020
    Report Date
    December 8, 2020
    Manufacturer
    NEXT ORTHOSURGICAL, INC.
    Product Code
    MNH
    PMA / PMN Number
    K141291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE HOSPITAL SEVERAL TIMES TO GATHER MORE INFORMATION BUT HAVE BEEN UNSUCCESSFUL IN OBTAINING.

    Description of Event or Problem · 1

    NEX D-2 CANNULATED SCREW. PATIENT NEEDED CORRECTION SURGERY DONE AS THE ROD CAME DISENGAGED WITH THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441237 NEX D 2 CANNULAED SCREW MNH NEXT ORTHOSURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR Other