BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 19130287 · Received April 18, 2024

    Report

    Report Number
    2031966-2024-00113
    Event Type
    Death
    Date Received
    April 18, 2024
    Date of Event
    March 30, 2024
    Report Date
    April 17, 2024
    Manufacturer
    NUVASIVE INC
    Product Code
    NKB
    UDI-DI
    00887517553935
    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 PRODUCT WAS RETURNED AS NO PRODUCT MALFUNCTION WAS ALLEGED. NO RADIOGRAPHS OR IMAGES OR LAB REPORTS WERE PROVIDED SO THE COMPLAINT CANNOT BE CONFIRMED. REVIEW OF THE REPORTED EVENT IDENTIFIED AN INFECTION WAS PRESENT PRIOR TO SURGERY. THE PHYSICIAN COMMENTED ANESTHESIA MAY HAVE BEEN THE CAUSE OF THE EVENT. THE ROOT CAUSE CANNOT BE DETERMINED ALTHOUGH ALLERGIC REACTION TO ANESTHESIA AND PREVIOUS PATIENT INFECTION PRIOR TO SURGERY MAY BE THE CAUSE OR CONTRIBUTOR TO THE EVENT. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED, IF ADDITIONAL INFORMATION IS PROVIDED ANOTHER REPORT WILL BE FILED. LABELING REVIEW: "CONTRAINDICATIONS INCLUDE, BUT ARE NOT LIMITED TO: 1. INFECTION, LOCAL TO THE OPERATIVE SITE. 2. SIGNS OF LOCAL INFLAMMATION... 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: EARLY OR LATE INFECTION... RARELY, SOME COMPLICATIONS MAY BE FATAL. POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: ... METAL SENSITIVITY OR ALLERGIC REACTION TO A FOREIGN BODY, INFECTION... DEATH." "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...CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT." 9401879-EN P-12/2018 H3 OTHER TEXT : DEVICE IN-SITU.

    Description of Event or Problem · 0

    ON (B)(6) 2024 A SPINAL PROCEDURE WAS CONDUCTED AT T10/L4. IT IS NOTED THE BLOOD PRESSURE DROPPED INTEROPERATIVELY WITH NO MEDICAL DEVICE MALFUNCTION OR BLEEDING. ON (B)(6) 2024 THE PATIENT DIED, BUT IT WAS NOT REPORTED TO THE REP UNTIL (B)(6) 2024. THE PHYSICIAN COMMENTED THAT THE PATIENT HAD AN INFECTION PRIOR TO SURGERY AND THAT ANESTHESIA MAY HAVE BEEN THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606577 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE INC 16017540 NI 00887517553935

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death RELINE POSTERIOR FIXATION CONSTRUCT