BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 16409644 · Received February 21, 2023

    Report

    Report Number
    2031966-2023-00029
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    February 9, 2023
    Report Date
    February 21, 2023
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKB
    UDI-DI
    00887517561084
    PMA / PMN Number
    K223181
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO NUVASIVE JAPAN AND PHOTOS WERE PROVIDED CONFIRMING THE DEVICE TIP WAS AS FRACTURED BUT NO RADIOGRAPHS COULD BE PROVIDED CONFIRMING THE UNRETRIEVED PORTION OF THE DEVICE. A DHR REVIEW OF THE REPORTED DEVICE BATCH IDENTIFIED IT HAS BEEN IN THE FIELD FOR ROUGHLY 4 YEARS. IT IS UNKNOWN WHETHER THE SURGEON UTILIZED A TORQUE HANDLE OR A HAND TIGHTENING DURING THE EVENT AND THE PATIENTS BONE QUALITY COULD NOT BE CONFIRMED. BASED ON THE INFORMATION PROVIDED THE ROOT CAUSE WAS DETERMINED TO BE A COMBINATION OF WEAR FATIGUE AND EXCESSIVE, OFF-ANGLED EXCESSIVE FORCE. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED. LABEL 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) 2023 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L2 TO SAI. WHILE INSERTING A PEDICLE SCREW AT L4 THE TIP OF THE DRIVER FRACTURED OFF IN THE ENGAGED SCREW HEAD. THE BROKEN PIECE COULD NOT BE RETRIEVED AND WAS LEFT IN-SITU. ANOTHER SCREWDRIVER WAS USED, AND THE FIXATION PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643259 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INCORPORATED 10000800 EM8685 00887517561084

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose