BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVALIGN

    MDR report key: 16728757 · Received April 12, 2023

    Report

    Report Number
    3005725110-2023-00003
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    March 20, 2023
    Report Date
    April 12, 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
    OTHER

    Narratives

    Description of Event or Problem · 0

    RECEIVED INFORMATION STATING PATIENT UNDERWENT A REVISION PROCEDURE DUE TO SCREW BACKOUTS.AS PER REPORTER THE COVER TABS OF BOTH SCREWS WERE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095745 CERVALIGN APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SURGALIGN SPINE TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H