BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE MODULUS XLIF INTERBODY SYSTEM

    MDR report key: 12797619 · Received November 11, 2021

    Report

    Report Number
    2031966-2021-00154
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    November 5, 2021
    Report Date
    November 11, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    MAX
    UDI-DI
    00887517881052
    PMA / PMN Number
    K201692
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS DISCARDED AT THE USER FACILITY AND COULD NOT BE RETURNED FOR EVALUATION. PATIENT'S BONE QUALITY AND POST-OP PHYSICAL ACTIVITY IS UNKNOWN. THE CONDITION OF THE PATIENT'S FACET JOINT PRIOR TO PROCEDURE IS UNKNOWN. THOUGH NO ROOT CAUSE CAN BE DETERMINED REVIEW OF THE REPORTED INFORMATION SUGGESTS EXCESSIVE POST-OPERATIVE PHYSICAL ACTIVITY, IMPLANT SELECTION/PLACEMENT OR THE PREVIOUSLY UNDIAGNOSED FACET JOINT DAMAGE AS POSSIBLE CAUSES OR CONTRIBUTORS. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED. LABELING REVIEW: "POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN SPINAL/ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES INCLUDE: DAMAGE TO BLOOD VESSELS, SPINAL CORD OR PERIPHERAL NERVES. POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: PAIN, DISCOMFORT OR ABNORMAL SENSATIONS DUE TO THE PRESENCE OF THE DEVICE, NERVE DAMAGE DUE TO SURGICAL TRAUMA." "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. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. THE POTENTIAL FOR SUCCESS IS INCREASED BY THE SELECTION OF THE PROPER SIZE OF THE IMPLANT. WHILE PROPER SELECTION CAN MINIMIZE RISKS, THE SIZE AND SHAPE OF HUMAN BONES PRESENT LIMITATIONS ON THE SIZE AND STRENGTH OF IMPLANTS. CARE SHOULD BE TAKEN TO ENSURE THAT ALL COMPONENTS ARE IDEALLY FIXATED PRIOR TO CLOSURE." "PRE-OPERATIVE WARNINGS: CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICES AND 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. THE PATIENT SHOULD BE INSTRUCTED TO LIMIT POSTOPERATIVE ACTIVITY, AS THIS WILL REDUCE THE RISK OF BENT, BROKEN OR LOOSE IMPLANT COMPONENTS. THE PATIENT MUST BE MADE AWARE THAT IMPLANT COMPONENTS MAY BEND, BREAK OR LOOSEN EVEN THOUGH RESTRICTIONS IN ACTIVITY ARE FOLLOWED."

    Description of Event or Problem · 0

    ON (B)(6) 2021 A PATIENT UNDERWENT A SPINAL PROCEDURE. ON (B)(6) 2021 THE PATIENT WAS BROUGHT IN DUE TO INCREASING LEG PAIN AND A REVISION PROCEDURE TOOK PLACE WHERE IT WAS DISCOVERED THAT BONE FROM THE FACET JOINT WAS IMPINGING A NERVE AND THE INTERBODY MIGRATED. THE IMPLANT WAS REMOVED AND DECOMPRESSION WAS CONDUCTED. THE PATIENT IS REPORTEDLY PAIN-FREE POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693117 NUVASIVE MODULUS XLIF INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE, INCORPORATED 2104304P2 ML1324 00887517881052

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose