BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVALIGN

    MDR report key: 15587773 · Received October 12, 2022

    Report

    Report Number
    3005725110-2022-00003
    Event Type
    Injury
    Date Received
    October 12, 2022
    Date of Event
    September 19, 2022
    Report Date
    November 17, 2022
    Manufacturer
    SURGALIGN SPINE TECHNOLOGIES
    Product Code
    KWQ
    PMA / PMN Number
    K211408
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS BEEN RECEIVED AND INVESTIGATION WAS COMPLETED. A MICROSCOPIC REVIEW OF TWO RETURNED CAMS WAS PERFORMED, AND VISUAL INSPECTION CONFIRMED A FRACTURE.

    Description of Event or Problem · 0

    RECEIVED INFORMATION STATING PATIENT UNDERWENT A REVISION SURGICAL PROCEDURE FOUR MONTHS POST INDEX SURGERY. AS PER REPORTER X-RAY SHOWED ONE OF THE SCREWS WAS BACKING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2896300 CERVALIGN APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SURGALIGN SPINE TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention