BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 13511964 · Received February 11, 2022

    Report

    Report Number
    1030489-2022-00135
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    Date of Event
    July 20, 2021
    Report Date
    February 11, 2022
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #: 6961460, PMA #: P060018, UDI: (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CERVICAL ARTIFICIAL DISC REPLACEMENT FOR MYELOPATHY (UPPER), MYELOPATHY (LOWER), HERNIATED DISC (UPPER), HERNIATED DISC (LOWER). LEVELS IMPLANTED: C4-C5. COMPLICATIONS: CANCER IT WAS REPORTED THAT SINKING OF THE IMPLANT INTO THE VERTEBRAL BODY WAS NOTICED DURING REGULAR IMAGING. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209972 PRESTIGE CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS 6971460 0742464W

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female