BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE LATERAL PLATE SYSTEM

    MDR report key: 3060649 · Received March 26, 2013

    Report

    Report Number
    2031966-2013-00010
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    December 21, 2012
    Report Date
    March 25, 2013
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K082070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF RADIOGRAPHS CONFIRMED THE REPORTED EVENT. THE PT HAS RECEIVED NO REVISION SURGERY; THE CONSTRUCT REMAINS IMPLANTED. IT IS UNK IF THE FALL CONTRIBUTED TO THE REPORTED EVENT. ROOT CAUSE OF THE EVENT IS UNK. LABELING REVIEW NOTES: "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADD'L SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NONUNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND VASCULAR OR VISCERAL INJURY..."

    Description of Event or Problem · 1

    APPROX ONE MONTH FOLLOWING CORPECTOMY AND IMPLANTATION OF A VERTEBRAL BODY REPLACEMENT CONSTRUCT, THE SCREWS WERE REPORTED TO HAVE BACKED OUT SEVERAL MILLIMETERS. THE PT WAS REPORTED TO HAVE FALLEN. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124618 NUVASIVE LATERAL PLATE SYSTEM SPINAL INTERVERTEBRAL BODY FIXATION ORTH KWQ NUVASIVE, INC. 7835540 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1