BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE PEEK CORPECTOMY RAILED SYSTEM

    MDR report key: 7037052 · Received November 16, 2017

    Report

    Report Number
    2031966-2017-00165
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    June 28, 2017
    Report Date
    November 16, 2017
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MQP
    UDI-DI
    00887517677150
    PMA / PMN Number
    K151538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION AS IT REMAINS IN-SITU. NO PRODUCT MALFUNCTION REPORTED. SURGICAL INCISION IS HEALING WELL AND NO EVIDENCE OF INFECTION HAS BEEN REPORTED. 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..."

    Description of Event or Problem · 1

    ON (B)(6) 2017, A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY ON C6-C7 LEVEL, CORPECTOMY C4 WITH INSERTION OF MONOLITH CAGE. DURING INDEX PROCEDURE THE DURA PROPER WAS DAMAGED AND THE ARACHNOID MEMBRANE WAS EXPOSED; COLLAGEN AND THROMBIN, WERE PLACED IN AN ATTEMPT TO SEAL DISK SPACE. TWO DAYS POST INDEX SURGERY PATIENT RETURNED TO THE OPERATING ROOM DUE TO CEREBRAL SPINAL LEAK IN THE CERVICAL AREA. PATIENT IS REPORTED TO BE HEALING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818323 NUVASIVE PEEK CORPECTOMY RAILED SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP NUVASIVE, INC. 5991416 00887517677150

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization