BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 16405810 · Received February 20, 2023

    Report

    Report Number
    2031966-2023-00027
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Date of Event
    January 27, 2023
    Report Date
    February 20, 2023
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKB
    UDI-DI
    00887517513724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED AND NO RADIOGRAPHS WERE PROVIDED CONFIRMING THE ALLEGED. NO LOT INFORMATION HAS BEEN PROVIDED AND THE PATIENTS BONE QUALITY COULD NOT BE CONFIRMED. WHILE A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED, PREVIOUS INVESTIGATIONS OF SIMILAR EVENTS HAVE FOUND THIS FAILURE IS TYPICALLY THE RESULT OF EXCESSIVE AND/OR OFF AXIS FORCES BEING APPLIED DURING USE OR DURING CLEANING/STERILE PROCESSING. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED AT THIS TIME. 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 DEVICE(S) 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.

    Description of Event or Problem · 0

    ON (B)(6) 2023 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L2 TO S1. DURING THE PROCEDURE THE DISTAL TIPS OF TWO DRIVERS FRACTURED OFF IN AN ENGAGED SCREWS AND WAS LEFT IN SITU ENCOMPASSED FLUSH UNDER THE LOCK SCREWS. IT COULD NOT BE CONFIRMED WHAT SIDE AND LEVEL THE FRACTURED DRIVER TIPS WERE LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320428 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INCORPORATED 10000751 NI 00887517513724

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose