BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE MODULUS XLIF INTERBODY SYSTEM

    MDR report key: 15396657 · Received September 9, 2022

    Report

    Report Number
    2031966-2022-00177
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 12, 2022
    Report Date
    September 9, 2022
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    MAX
    UDI-DI
    00887517452764
    PMA / PMN Number
    K201692
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND THE COMPLAINT WAS CONFIRMED. DHR REVIEW OF THE REPORTED DEVICE IDENTIFIED WITH RELEASE TO THE FIELD IN 2017. EXAMINATION OF THE RETURNED DEVICE WAS COMPLETED BY NUVASIVE AND THE FRACTURE PATTERN IDENTIFIED IS CONSISTENT WITH EXCESSIVE FORCE. REVIEW OF THE RETURNED DEVICE AND REPORTED EVENT SUGGESTS THE FRACTURE WAS THE RESULT OF OFF ANGLED EXCESSIVE FORCE AND CONSIDERED AN INADVERTENT USE ERROR. NO ADDITIONAL INVESTIGATION NECESSARY. LABELING REVIEW: "PATIENT EDUCATION: PREOPERATIVE INSTRUCTIONS TO THE PATIENT ARE ESSENTIAL. THE PATIENT SHOULD BE MADE AWARE OF THE POTENTIAL RISKS OF THE SURGERY." "DO NOT IMPLANT THE INSTRUMENTS: COMPLICATIONS TO THE PATIENT MAY INCLUDE, BUT ARE NOT LIMITED TO: BREAKAGE OF THE DEVICE, WHICH COULD MAKE NECESSARY REMOVAL DIFFICULT OR SOMETIMES IMPOSSIBLE, WITH POSSIBLE CONSEQUENCES OF LATE INFECTION AND MIGRATION. BREAKAGE COULD CAUSE INJURY TO THE PATIENT." "PRE-OPERATIVE WARNINGS: THE METHOD OF USE FOR THE INSTRUMENTS ARE TO BE DETERMINED BY THE USER¿S EXPERIENCE AND TRAINING IN SURGICAL PROCEDURES. THE INSTRUMENTS SHOULD BE TREATED AS ANY PRECISION INSTRUMENT AND SHOULD BE CAREFULLY PLACED ON TRAYS, CLEANED AFTER EACH USE, AND STORED, ACCORDING TO GENERALLY ACCEPTED HOSPITAL METHODS AND PRACTICES. THE INSTRUMENTS SHOULD BE CAREFULLY EXAMINED PRIOR TO USE FOR FUNCTIONALITY, EXCESSIVE WEAR, OR DAMAGE. A DAMAGED INSTRUMENT SHOULD NOT BE USED AS THIS MAY INCREASE THE RISK OF MALFUNCTION AND POTENTIAL PATIENT INJURY. CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICES AND INJURY TO THE PATIENT." "INTRA-OPERATIVE WARNINGS: THE PHYSICIAN SHOULD TAKE PRECAUTIONS AGAINST PUTTING UNDUE STRESS ON THE SPINAL AREA WITH INSTRUMENTS. ANY SURGICAL TECHNIQUE SHOULD BE CAREFULLY FOLLOWED. IT IS IMPORTANT THAT THE SURGEON EXERCISE EXTREME CAUTION WHEN WORKING IN CLOSE PROXIMITY TO VITAL ORGANS, NERVES, OR VESSELS, AND THAT THE FORCE APPLIED TO THE INSTRUMENTATION IS NOT EXCESSIVE, TO PREVENT POTENTIAL INJURY TO THE PATIENT. OVER-BENDING, NOTCHING, STRIKING, AND/OR SCRATCHING OF IMPLANTS WITH ANY INSTRUMENT SHOULD BE AVOIDED TO REDUCE THE RISK OF BREAKAGE. THE PHYSICAL CHARACTERISTICS REQUIRED FOR MANY INSTRUMENTS DO NOT PERMIT THEM TO BE MANUFACTURED FROM IMPLANTABLE MATERIALS. IF ANY BROKEN FRAGMENTS OF INSTRUMENTS REMAIN IN THE BODY OF A PATIENT, THEY COULD CAUSE ALLERGIC REACTIONS OR INFECTIONS. IF AN INSTRUMENT BREAKS IN SURGERY AND FRAGMENTS GO INTO THE PATIENT, THESE PIECES SHOULD BE REMOVED PRIOR TO CLOSURE AND SHOULD NOT BE IMPLANTED."

    Description of Event or Problem · 0

    ON (B)(6) 2022, DURING A SPINAL PROCEDURE THE TOP PITUITARY TIP BROKE OFF. THE PIECES WERE RETRIEVED AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138954 NUVASIVE MODULUS XLIF INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE, INCORPORATED 6940429 FD5975440 00887517452764

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose