BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVALIGN

    MDR report key: 16250803 · Received January 26, 2023

    Report

    Report Number
    3005725110-2023-00001
    Event Type
    Injury
    Date Received
    January 26, 2023
    Date of Event
    December 22, 2022
    Report Date
    January 26, 2023
    Manufacturer
    SURGALIGN SPINE TECHNOLOGIES
    Product Code
    KWQ
    PMA / PMN Number
    K211408
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RECEIVED INFORMATION STATING PATIENT UNDERWENT A REVISION PROCEDURE AS PATIENT EXPERIENCED TWO SCREW BACKOUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407717 CERVALIGN APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SURGALIGN SPINE TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention