BEUDAMED
    FDA Adverse Event Other Summary report: N

    GRADIENT PLUS

    MDR report key: 3608649 · Received January 9, 2014

    Report

    Report Number
    2031966-2013-00097
    Event Type
    Other
    Date Received
    January 9, 2014
    Date of Event
    December 9, 2013
    Report Date
    January 22, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K053581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS TO GAIN ADD'L INFO ABOUT THE ALLEGED EVENT HAVE BEEN MADE. ROOT CAUSE OF THE EVENT IS UNK. IF ADD'L INFO IS OBTAINED, A F/U REPORT WILL BE MADE.

    Description of Event or Problem · 1

    A CERVICAL BONE SCREW REPORTEDLY BACKED OUT OF A CERVICAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15628 GRADIENT PLUS SPINAL FIXATION SYSTEM KWQ NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1