BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX

    MDR report key: 24845647 · Received April 10, 2026

    Report

    Report Number
    3025435185-2026-00001
    Event Type
    Injury
    Date Received
    April 10, 2026
    Report Date
    April 9, 2026
    Manufacturer
    PARADIGM SPINE GMBH
    Product Code
    NQO
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE REPEATED REQUESTS TO THE AUTHORS OF THE ARTICLE, WHICH WENT UNANSWERED, IT WAS IMPOSSIBLE TO GATHER RELIABLE, PROPERLY CITED ADDITIONAL DATA THAT WOULD HAVE ALLOWED FOR A COMPREHENSIVE INVESTIGATION. BECAUSE A SUBSTANTIAL PORTION OF THE ADVERSE EVENTS IN THE HEO STUDY OCCURRED IN PATIENTS WHO WOULD NOT HAVE BEEN ELIGIBLE FOR COFLEX IMPLANTATION UNDER THE FDA APPROVED LABELING, THE FINDINGS CANNOT BE GENERALIZED TO THE INDICATED U.S. PATIENT POPULATION. THE ADVERSE EVENTS DESCRIBED ARE CONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU) AND PRODUCT LABELING ACCORDING TO INFORMATION PRESENTED IN THE ARTICLE. THE LONG-TERM COMPLICATIONS REPORTED IN THE ARTICLE DO NOT ALTER THE PRODUCT'S RISK-BENEFIT RATIO. COMPANION SPINE CONTINUES IN ITS EFFORTS TO REACH THE STUDY AUTHORS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE "JOURNAL OF CLINICAL MEDECINE" AN ARTICLE BY HEO ET AL OF APRIL 2025 THERE WERE 29 PROCEDURE RELATED ADVERSE EVENTS OBSERVED INCLUDING INSTABILITY (12), INFECTION (1), INTOLERANCE (1), THAT HAD REQUIRED DEVICE EXPLANTATION AND FRACTURE (11), MIGRATION (2), BENDING (2) THAT WERE NOT ASSOCIATED WITH ANY REOPERATION. NO IDENTIFYING INFORMATION WAS AVAILABLE BUT AT LEAST THE DEVICES APPEARED TO HAVE BEEN MANUFACTURED BY PARADIGM SPINE GMBH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905827 COFLEX COFLEX INTERLAMINAR TECHNOLOGY NQO PARADIGM SPINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention