BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE RELINE CERVICAL SYSTEM

    MDR report key: 20781603 · Received November 26, 2024

    Report

    Report Number
    2031966-2024-00317
    Event Type
    Death
    Date Received
    November 26, 2024
    Date of Event
    September 18, 2024
    Report Date
    November 25, 2024
    Manufacturer
    NUVASIVE INC.
    Product Code
    NKG
    PMA / PMN Number
    K221388
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTION WAS ALLEGED, NO LAB REPORTS OR IMAGES PROVIDED SO THE COMPLAINT COULD NOT BE CONFIRMED. NO PATIENT COMORBIDITIES WERE PROVIDED. REVIEW OF THE STUDY REPORT NOTED NO PRODUCT MALFUNCTION OR PROCEDURAL ERROR IDENTIFIED AND THE DEATH WAS REPORTED AS A CARDIAC ARREST AND APPEARS TO BE UNRELATED TO NUVASIVE DEVICES UTILIZED ALTHOUGH NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. LABELING REVIEW: "CONTRAINDICATIONS INCLUDE BUT ARE NOT LIMITED TO: 6. PATIENTS WITH PHYSICAL OR MEDICAL CONDITIONS THAT WOULD PROHIBIT BENEFICIAL SURGICAL OUTCOME..." "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...RARELY, SOME COMPLICATIONS MAY BE FATAL..." "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE... NEUROLOGICAL, VASCULAR OR VISCERAL INJURY...DEATH." "WARNINGS, CAUTION AND PRECAUTIONS THE SUBJECT DEVICE IS INTENDED FOR USE ONLY AS INDICATED. THE IMPLANTATION OF SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS SPINAL SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT." "PATIENT EDUCATION: PREOPERATIVE INSTRUCTIONS TO THE PATIENT ARE ESSENTIAL. THE PATIENT SHOULD BE MADE AWARE OF THE LIMITATIONS OF THE IMPLANT AND POTENTIAL RISKS OF THE SURGERY..." "PRE-OPERATIVE WARNINGS USE OF CROSS-SECTIONAL IMAGING (I.E., CT AND/OR MRI) FOR POSTERIOR CERVICAL SCREW PLACEMENT IS RECOMMENDED DUE TO THE UNIQUE RISKS IN THE CERVICAL SPINE. THE USE OF PLANAR RADIOGRAPHS ALONE MAY NOT PROVIDE THE NECESSARY IMAGING TO MITIGATE THE RISK OF IMPROPER SCREW PLACEMENT. IN ADDITION, USE OF INTRAOPERATIVE IMAGING SHOULD BE CONSIDERED TO GUIDE AND/OR VERIFY DEVICE PLACEMENT, AS NECESSARY. 1. ONLY PATIENTS THAT MEET THE CRITERIA DESCRIBED IN THE INDICATIONS SHOULD BE SELECTED. 2. PATIENT CONDITION AND/OR PREDISPOSITIONS SUCH AS THOSE ADDRESSED IN THE AFOREMENTIONED CONTRAINDICATIONS SHOULD BE AVOIDED...5. CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT." "METHOD OF USE PLEASE REFER TO THE SURGICAL TECHNIQUE FOR THIS DEVICE." "TO OBTAIN A SURGICAL TECHNIQUE MANUAL OR SHOULD ANY INFORMATION REGARDING THE PRODUCTS OR THEIR USES BE REQUIRED, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR NUVASIVE DIRECTLY AT..." (B)(4).

    Description of Event or Problem · 0

    THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE POSTERIOR CERVICAL FUSION STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2024 A PATIENT UNDERWENT A SEVEN LEVEL POSTERIOR CERVICAL FIXATION PROCEDURE AT C2 TO T2. POST-OPERATIVE CHECK WAS COMPLETED AT 5:44 PM AND NOTED NO ACUTE ABNORMALITIES. ON (B)(6) 2024 THE NIGHT CONSULT TEAM WAS PAGED AT 4:02 AM THAT A STAT HAD BEEN CALLED AND PATIENT WAS UNRESPONSIVE WITH A CODE CALLED. 9NINE ROUNDS OF EPI WITHOUT ROSC WERE ADMINISTERED, THE ENTIRE STAT TEAM DECIDED THERE WERE NO OTHER INTERVENTIONS THAT WERE DEEMED APPROPRIATE AND IT WAS DECIDED TO END THE CODE. A TIME OF DEATH WAS CALLED AS CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441745 NUVASIVE RELINE CERVICAL SYSTEM POSTERIOR CERVICAL SCREW SYSTEM NKG NUVASIVE INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Death