BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE POLYAXIAL SPINAL SCREWS

    MDR report key: 6893449 · Received September 26, 2017

    Report

    Report Number
    2031966-2017-00127
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    August 31, 2017
    Report Date
    September 26, 2017
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NBK
    PMA / PMN Number
    K121619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION NOR WERE X-RAYS PROVIDED TO CONFIRM THE EVENT. POTENTIAL ADVERSE EVENTS AND COMPLICATIONS "AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES INCLUDE; LOSS OF SENSORY AND/OR MOTOR FUNCTION..." "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S) PAIN, DISCOMFORT OR ABNORMAL SENSATIONS DUE TO THE PRESENCE OF THE DEVICE..." NO PRODUCT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN (B)(6) 2016, A PATIENT UNDERWENT POSTERIOR SPINAL FUSION AT THE T9-L3 LEVELS. REPORTEDLY, THE PATIENT DEVELOPED POST-OPERATIVE RADICULOPATHY DUE TO SCREW LOOSENING AT RIGHT SIDE OF THE L3 LEVEL. ON (B)(6) 2017, A REVISION PROCEDURE WAS PERFORMED TO REPLACE THE LOOSENED SCREW AND EXTEND THE CONSTRUCT TO THE L5 LEVEL. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676171 NUVASIVE POLYAXIAL SPINAL SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NBK NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1