BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX INTERLAMINAR TECHNOLOGY

    MDR report key: 16820635 · Received April 26, 2023

    Report

    Report Number
    3005725110-2023-00004
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    April 6, 2023
    Report Date
    June 22, 2023
    Manufacturer
    SURGALIGN SPINE TECHNOLOGIES
    Product Code
    PEK
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ADDITIONAL INFORMATION RELATED TO PATIENT HISTORY. SECTION B7 HAS BEEN UPDATED, PATIENT UNDERWENT IMPLANT COFLEX PROCEDURE IN 2021 NO EXACT DATE PROVIDED.

    Description of Event or Problem · 0

    DURING A FOLLOW UP CLINICAL STUDY INFORMATION WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE TO REMOVE A COFLEX DEVICE. NO ALLEGATION OF PRODUCT MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612905 COFLEX INTERLAMINAR TECHNOLOGY SPINOUS PROCESS PLATE PEK SURGALIGN SPINE TECHNOLOGIES UQI00010 2015AA1533

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R