BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE® RELINE® SYSTEM

    MDR report key: 7484970 · Received May 3, 2018

    Report

    Report Number
    2031966-2018-00049
    Event Type
    Injury
    Date Received
    May 3, 2018
    Date of Event
    April 13, 2016
    Report Date
    May 3, 2018
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K160989
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION AS THERE WAS NO PRODUCT MALFUNCTION REPORTED. NO X-RAYS, MRI OR CAT SCAN RESULTS PROVIDED TO CONFIRM THE ALLEGED EVENT. ROD FRACTURE PROCEDURE WAS REPORTED UNDER MDR 2031966-2018-00048. NO PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2016 PATIENT UNDERWENT A REVISION PROCEDURE DUE TO ROD FRACTURE AND LOOSE PEDICLE SCREW WITH NO REPORTED PROBLEMS. POST PHYSICAL THERAPY THE PATIENT EXPERIENCED LEFT LOWER EXTREMITY PARESTHESIA AND WEAKNESS. AN MRI AND CAT SCAN WERE PERFORMED AND NO CONCLUSIVE FINDINGS WERE NOTED. AN EXPLORATION PROCEDURE WAS PERFORMED ON (B)(6) 2018 WHERE A HEMATOMA AT THE LUMBOSACRAL AREA WAS IDENTIFIED. THE HEMATOMA HAS BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327720 NUVASIVE® RELINE® SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention