BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLIFY DISC

    MDR report key: 11905719 · Received May 29, 2021

    Report

    Report Number
    3012070713-2021-00003
    Event Type
    Injury
    Date Received
    May 29, 2021
    Date of Event
    April 29, 2021
    Report Date
    May 28, 2021
    Manufacturer
    SIMPLIFY MEDICAL, INC
    Product Code
    MJO
    PMA / PMN Number
    P200022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    LDE PATIENT: (B)(6), PATIENT HAS HAD 60 MONTH FOLLOW-UP. RECENTLY INCREASING NECK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802073 SIMPLIFY DISC SIMPLIFY DISC MJO SIMPLIFY MEDICAL, INC 57035 3055

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention