BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVALIGN

    MDR report key: 16727021 · Received April 12, 2023

    Report

    Report Number
    3005725110-2023-00002
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    March 17, 2023
    Report Date
    April 11, 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 WHICH ALLEGED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO SCREW BACK OUT. AS PER REPORTER ONCE THE PLATE WAS EXPOSED IT WAS NOTICED THAT THE LCOKING MECHANISM WAS BROKEN ON THE BOTTOM LEVEL OF THE PLATE. NO PRODUCT OR XRAY HAVE BEEN PROVIDED TO CONFIRM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212342 CERVALIGN APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SURGALIGN SPINE TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R