BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE® VUEPOINT® II OCT SYSTEM

    MDR report key: 8630084 · Received May 21, 2019

    Report

    Report Number
    2031966-2019-00199
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    March 22, 2019
    Report Date
    April 26, 2019
    Manufacturer
    NUVASIVE INC.
    Product Code
    NKG
    PMA / PMN Number
    K180198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. RADIOGRAPHS PROVIDED WERE FOR A POST-OPERATIVE EVENT REPORTED UNDER 2031966-2019-00198. AS PER REPORTER PRODUCT WAS PLACED TOO MEDIAL.

    Description of Event or Problem · 1

    ON (B)(6) 2019 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE AT C2-T2 LEVELS. POST OPERATIVE IMAGES IDENTIFIED C5 LEFT SCREW WAS MALPLACED TOO MEDIAL. ON (B)(6) 2019 A REVISION PROCEDURE WAS PERFORMED WHERE THE C5 LEFT SCREW WAS REMOVED AND REPLACED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423197 NUVASIVE® VUEPOINT® II OCT SYSTEM POSTERIOR CERVICAL SCREW SYSTEM NKG NUVASIVE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization