BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE MODULUS XLIF INTERBODY SYSTEM

    MDR report key: 15134318 · Received July 29, 2022

    Report

    Report Number
    2031966-2022-00134
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    April 7, 2022
    Report Date
    July 29, 2022
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    MAX
    UDI-DI
    00887517913425
    PMA / PMN Number
    K201692
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO THE US BUT PHOTOGRAPH PROVIDED CONFIRMED THE COMPLAINT. REVIEW OF THE PHOTOGRAPH WAS UNABLE TO OBSERVE THE FRACTURE PATTERN. DHR REVIEW OF THE REPORTED DEVICE IDENTIFIED IT HAS BEEN IN THE FIELD FOR OVER 2.5 YEARS. THOUGH NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED REVIEW OF THE PROVIDED PHOTOGRAPH AND COMPLAINT REPORT SUGGESTS OFF ANGLED EXCESSIVE FORCE AND OR AGED WEAR FATIGUE AS POSSIBLE CAUSE OR CONTRIBUTORS. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED. 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. WHEN USING THE MAXCESS MAS TLIF SYSTEM FOR DISTRACTION CARE MUST BE TAKEN TO AVOID DAMAGING THE PEDICLES WHICH COULD COMPROMISE PEDICLE SCREW PURCHASE. 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." DEVICE NOT RETURNED TO US.

    Description of Event or Problem · 0

    ON (B)(6) 2022 DURING A SPINAL PROCEDURE DURING INSERTION OF THE CAGE AT L4/5 THE TIP OF THE INSERTER BROKE OFF AND THE FRAGMENT REMAINED IN THE CAGE. THE SURGEON DECIDED NOT TO REMOVE THE CAGE THEREFORE THE FRAGMENT REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2655645 NUVASIVE MODULUS XLIF INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE, INCORPORATED 1775850 EM39982 00887517913425

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose