BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 19374931 · Received May 22, 2024

    Report

    Report Number
    2031966-2024-00141
    Event Type
    Death
    Date Received
    May 22, 2024
    Date of Event
    May 14, 2024
    Report Date
    May 22, 2024
    Manufacturer
    NUVASIVE INC.
    Product Code
    NKB
    PMA / PMN Number
    K223181
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICES WERE RETURNED TO NUVASIVE FOR EVALUATION AS THE WAS NO REPORTED DEVICE OR PROCEDURAL PROBLEM WAS REPORTED OR IDENTIFIED. NO INFORMATION WAS PROVIDED RELATED TO CAUSE OF DEATH SO NO ROOT CAUSE COULD BE DETERMINED HOWEVER REVIEW OF THE PROVIDED PATIENT INFORMATION IDENTIFIED THIS AS A DIALYSIS PATIENT WHICH MAY HAVE BEEN A CONTRIBUTOR. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED AT THIS TIME, SHOULD MORE INFORMATION BECOME AVAILABLE AN ADDITIONAL REPORT WILL BE FILED. LABELING REVIEW: "CONTRAINDICATIONS 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...DEATH". "WARNINGS, CAUTIONS AND PRECAUTIONS...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 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.". "INFORMATION 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..." 9401879-EN P-12/2018.

    Description of Event or Problem · 0

    ON (B)(6) 2024 A PATIENT UNDERWENT AN ANTERIOR THORACIC LUMBAR INTERBODY FUSION PROCEDURE WITH ANTERIOR/POSTERIOR FIXATION FROM T11/L4. NUVASIVE CAGE PLACED AT L1/2 AND ANOTHER MANUFACTURES CAGES WERE PLACED AT L2/3 AND L3/4. (B)(6) 2024: UNOFFICIAL INFORMATION WAS RECEIVED FROM THE OPERATING ROOM STAFF THAT THE PATIENT HAD DIED POSTOPERATIVELY. NO ADDITIONAL DETAILS WERE PROVIDED BY THE PHYSICIAN OR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451984 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Death UNKNOWN COROENT AT INTERBODY.| UNKNOWN RELINE FIXATION DEVICES.| UNKNOWN VERSATIE FIXATION.