BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE POLYAXIAL SPINAL SCREWS

    MDR report key: 6719905 · Received July 17, 2017

    Report

    Report Number
    2031966-2017-00091
    Event Type
    Injury
    Date Received
    July 17, 2017
    Date of Event
    May 9, 2017
    Report Date
    July 17, 2017
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NBK
    PMA / PMN Number
    K121619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT OR RADIOGRAPHS WERE PROVIDED FOR EVALUATION. ROD WAS REMOVED TO PERFORM DECOMPRESSION AND PLACED BACK. NO KNOWN MALFUNCTION NOR ALLEGATION OF PRODUCT PROBLEM REPORTED. REMAINS IN-SITU.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING, A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. THE LEFT SIDE ROD WAS REMOVED TO PERFORM DECOMPRESSION AND THE ROD WAS PLACED BACK. NO ALLEGATION OF PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500956 NUVASIVE POLYAXIAL SPINAL SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NBK NUVASIVE, INC. 8806545006

    Patients

    Seq Age Sex Outcome Treatment
    1