BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVALIGN

    MDR report key: 15246175 · Received August 17, 2022

    Report

    Report Number
    3005725110-2022-00002
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    July 22, 2022
    Report Date
    July 22, 2022
    Manufacturer
    SURGALIGN SPINE TECHNOLOGIES
    Product Code
    KWQ
    PMA / PMN Number
    K211408
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THREE WEEKS POST OPERATIVE, PATIENT STARTED TO EXPERIENCE INCREASED PAIN AND DIFFICULTY SWALLOWING. A SIX-WEEK RADIOGRAPH IDENTIFIED A SUSPECTED SCREW BACK-OUT OF THE CAUDAL LEVEL. PATIENT REPORTED EXPERIENCING A FALL POST INITIAL SURGERY. PATIENT WAS SCHEDULED FOR A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278687 CERVALIGN APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SURGALIGN SPINE TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention