BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE® COROENT® THORACOLUMBAR SYSTEM

    MDR report key: 7551522 · Received May 29, 2018

    Report

    Report Number
    2031966-2018-00071
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    June 6, 2012
    Report Date
    May 29, 2018
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K170962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION NOR WERE RADIOGRAPHS PROVIDED TO CONFIRM THE ALLEGED EVENT. IT IS UNKNOWN IF FLUOROSCOPY WAS USED AT THE TIME OF EVENT. LABELING REVIEW: "...PROPER ANTERIOR/POSTERIOR POSITION IS VERIFIED USING LATERAL FLUOROSCOPY..." RELATED MDR WAS SUBMITTED UNDER REPORT 2031966-2018-00070. NO PRODUCT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE. ON (B)(6) 2012 PATIENT UNDERWENT A REVISION PROCEDURE DUE TO SCREW MALPOSITION ON L4-5 LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391820 NUVASIVE® COROENT® THORACOLUMBAR SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1