BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLIFY® CERVICAL ARTIFICIAL DISC

    MDR report key: 13361945 · Received January 26, 2022

    Report

    Report Number
    2031966-2022-00018
    Event Type
    Injury
    Date Received
    January 26, 2022
    Date of Event
    December 16, 2021
    Report Date
    September 15, 2022
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MJO
    UDI-DI
    00843285101952
    PMA / PMN Number
    P200022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PRODUCT RETURNED AND THERE WAS NO PRODUCT PROBLEM IDENTIFIED. THE DEVICES REMAIN IN-SITU WITH NO REPORTED PLANS TO REMOVE OR REVISE, AND NO OTHER TREATMENTS OR ACTIONS HAVE BEEN TAKEN IN RELATION TO THE REPORTED EVENT. A DEFINITIVE CAUSE OF THE REPORTED OSSIFICATION CANNOT BE DETERMINED. LABEL REVIEW: "THERE IS A RISK OF HETEROTOPIC OSSIFICATION ASSOCIATED WITH ARTIFICIAL CERVICAL DISCS WHICH COULD LEAD TO REDUCED CERVICAL MOTION OR FUSION AT EITHER THE TREATED LEVEL(S) OR ADJACENT LEVELS." IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    DUPLICATE OF MFR: 2031966-2021-00170. ALL INFORMATION PREVIOUSLY RECORDED ON MFR: 2031966- 2021-00170.

    Description of Event or Problem · 0

    VIA CLINICAL STUDY, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HETEROTOPIC OSSIFICATION AT THE INDEX LEVELS 36 MONTHS AFTER THEIR INDEX PROCEDURE AT C4/5 AND C5/6 WITH SIMPLIFY IMPLANTS. THERE HAS BEEN NO REPORTED TREATMENT FOR THE REPORTED CONDITION AND THERE ARE NO REPORTED PLANS TO REMOVE OR REVISE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED VIA SIMPLIFY DISC LEVEL 2 RETROSPECTIVE STUDY REVIEW THAT AN INDEX CERVICAL PROCEDURE WAS COMPLETED AT INDEX LEVEL OF C4/6 FOR PATIENT (B)(6) ON AN UNKNOWN DATE. ON THEIR 36 MONTH ON (B)(6) 2021 IT WAS REPORTED THAT THERE WAS HETEROTOPIC OSSIFICATION WAS OBSERVED. THERE WAS NO TREATMENT PLAN GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44498 SIMPLIFY® CERVICAL ARTIFICIAL DISC PROSTHESIS, INTERVERTEBRAL DISC MJO NUVASIVE, INC. 2-4-CE 3451 00843285101952

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other