NuVasive

NuVasive X-CORE Expandable VBR System

2 Pages

$EC REP NUVASIVE NETHERLANDS B.V. JACHTHAVENWEG 109A 1081 KM AMSTERDAM THE NETHERLANDS PHONE: +31 20 72 33 000 NUVASIVE, INC. 7475 LUSK BOULEVARD SAN DIEGO, CA 92121, USA PHONE: +1-800-475-9131 WWW.NUVASIVE.COM AUSTRALIAN SPONSOR: NUVASIVE AUSTRALIA & NZ PTY LTD. BUILDING 9 588A SWAN STREET RICHMOND VIC 3121 MELBOURNE, AUSTRALIA UK RESPONSIBLE PERSON: NUVASIVE UK LIMITED SUITE B, GROUND FLOOR, CASPIAN HOUSE, THE WATERFRONT, ELSTREE, HERTS, WD6 3BS, UNITED KINGDOM NUVASIVE SWITZERLAND GMBH C/O DOMENGHINI & PARTNERS AG FALKENGASSE 3 6004 LUZERN, SWITZERLAND NUVASIVE X-CORE EXPANDABLE VBR SYSTEM NUVASIVE X-CORE MINI CERVICAL EXPANDABLE VBR SYSTEM INSTRUCTIONS FOR USE For Symbols Glossary, please refer to https://www.nuvasive.com/eifu/symbols-glossary MATL Ti-6Al-4V ELI ENGLISH DESCRIPTION The NuVasive X-CORE Expandable VBR System and the NuVasive X-Core Mini Cervical Expandable VBR System are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3. The implants are available in a variety of sizes to accommodate anatomical conditions. INDICATIONS FOR USE X-CORE EXPANDABLE VBR SYSTEM The NuVasive X-CORE Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive X-CORE Expandable VBR System is intended to be used with supplemental internal spinal fixation systems. X-CORE MINI CERVICAL EXPANDABLE VBR SYSTEM The NuVasive X-Core Mini Cervical Expandable VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive X-Core Mini Cervical Expandable VBR System is intended to be used with supplemental fixation for use in the cervical spine. The NuVasive X-Core Mini Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion. CONTRAINDICATIONS Contraindications include, but are not limited to: 1. Infection, local to the operative site. 2. Signs of local inflammation. 3. Patients with known sensitivity to the materials implanted. 4. Patients who are unwilling to restrict activities or follow medical advice. 5. Patients with inadequate bone stock or quality. 6. Patients with physical or medical conditions that would prohibit beneficial surgical outcome. 7. Use with components of other systems. 8. Reuse or multiple uses. Rx ONLY POTENTIAL ADVERSE EVENTS AND COMPLICATIONS As with any major surgical procedures, there are risks involved in orthopedic surgery. Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; dysphagia; dysphonia; dural tear or CSF leak; esophageal injury; worsened neurologic status; vertebral artery injury; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity. Rarely, some complications may be fatal. Potential risks identified with the use of this system, which may require additional surgery, include:  Bending, fracture or loosening of implant component(s)  Loss of fixation  Nonunion or delayed union  Fracture of the vertebra  Implant subsidence  Neurological, vascular or visceral injury  Spinal cord or nerve root injury (particularly C5) due to over-distraction  Nerve damage due to surgical trauma  Metal sensitivity or allergic reaction to a foreign body  Infection  Decrease in bone density due to stress shielding  Pain, discomfort or abnormal sensations due to the presence of the device  Bursitis  Dural leak  Paralysis  Death WARNINGS, CAUTIONS AND PRECAUTIONS The subject device is intended for use only as indicated. 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. Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone. These devices are not designed to withstand the unsupported stress of full weight or load bearing alone. Based on fatigue testing results, when using the X-Core Expandable VBR System and the X-Core Mini Cervical Expandable VBR System, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system. Careful preoperative planning, intraoperative sizing, radiographic confirmation of proper spinal segment height restoration, and intraoperative neuromonitoring are critical in avoiding spinal cord and nerve root injuries that may be caused by over-distraction. Do not over-distract the spinal segment. Careful preoperative planning and intraoperative sizing to maximize endplate coverage are important in helping avoid implant subsidence. Caution must be taken due to potential patient sensitivity to materials. Do not implant in patients with known or suspected sensitivity to the aforementioned materials. These devices can break when subjected to the increased load associated with delayed union or nonunion. Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs. If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break. Loads on the device produced by load bearing and by the patient’s activity level will dictate the longevity of the implant. Corrosion of the implant can occur. Implanting metals and alloys in the human body subjects them to a constantly changing environment of salts, acids, and alkalis, which can cause corrosion. Placing dissimilar metals (e.g., titanium and stainless steel) in contact with each other can accelerate the corrosion process, which in turn, can enhance fatigue fractures of implants. Consequently, every effort should be made to use compatible metals and alloys in conjunction with each other. When used in the cervical spine at one or two levels, the NuVasive X-Core Mini Cervical Expandable VBR System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation. Avoid excessive distraction to decrease the risk of overdistraction causing neurologic injury. When delivering the X-Core Mini Cervical Expandable VBR device, use radiographic confirmation and intraoperative neuromonitoring to reduce the risk of potential spinal cord and nerve root injuries that may be caused by over-distraction. Confirm that the height of the restored spinal segment on intraoperative radiographs is consistent with preoperative planning. Place supplemental fixation (e.g., anterior plate and/or posterior cervical screw fixation system) at the necessary levels to reduce the risk of implant subsidence and vertebral body fracture as well as the potential for implant migration. Additional posterior supplemental fixation may be required in some cases for adequate stabilization. See the supplemental fixation system instructions for use and surgical technique for instructions. All components should be final tightened per the specifications in the Surgical Technique. Implants should not be tightened past the locking point, as damage to the implant may occur. In order to ensure proper inserter/implant engagement, the inserter’s colored distal tip must face up toward the like-colored spinning sleeve of the implant. To ensure proper anatomical alignment, the rounded corners of the X-Core shape endcaps must face anterior during implant construction and placement. Care should be taken to ensure that all components are ideally fixated prior to closure. 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. Single Use/Do Not Re-Use: Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure, material degradation, potential leachables, and transmission of infectious agents. Page 1 of 2 9400903998-EN L-2022-02$

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EC REP

NUVASIVE NETHERLANDS B.V. JACHTHAVENWEG 109A 1081 KM AMSTERDAM THE NETHERLANDS PHONE: +31 20 72 33 000

NUVASIVE, INC. 7475 LUSK BOULEVARD SAN DIEGO, CA 92121, USA PHONE: +1-800-475-9131 WWW.NUVASIVE.COM

AUSTRALIAN SPONSOR: NUVASIVE AUSTRALIA & NZ PTY LTD. BUILDING 9 588A SWAN STREET RICHMOND VIC 3121 MELBOURNE, AUSTRALIA

UK RESPONSIBLE PERSON: NUVASIVE UK LIMITED SUITE B, GROUND FLOOR, CASPIAN HOUSE, THE WATERFRONT, ELSTREE, HERTS, WD6 3BS, UNITED KINGDOM

NUVASIVE SWITZERLAND GMBH C/O DOMENGHINI & PARTNERS AG

FALKENGASSE 3 6004 LUZERN, SWITZERLAND

NUVASIVE X-CORE EXPANDABLE VBR SYSTEM NUVASIVE X-CORE MINI CERVICAL EXPANDABLE VBR SYSTEM INSTRUCTIONS FOR USE For Symbols Glossary, please refer to https://www.nuvasive.com/eifu/symbols-glossary

MATL

Ti-6Al-4V ELI

ENGLISH DESCRIPTION The NuVasive X-CORE Expandable VBR System and the NuVasive X-Core Mini Cervical Expandable VBR System are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3. The implants are available in a variety of sizes to accommodate anatomical conditions. INDICATIONS FOR USE X-CORE EXPANDABLE VBR SYSTEM The NuVasive X-CORE Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive X-CORE Expandable VBR System is intended to be used with supplemental internal spinal fixation systems. X-CORE MINI CERVICAL EXPANDABLE VBR SYSTEM The NuVasive X-Core Mini Cervical Expandable VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive X-Core Mini Cervical Expandable VBR System is intended to be used with supplemental fixation for use in the cervical spine. The NuVasive X-Core Mini Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion. CONTRAINDICATIONS Contraindications include, but are not limited to: 1. Infection, local to the operative site. 2. Signs of local inflammation. 3. Patients with known sensitivity to the materials implanted. 4. Patients who are unwilling to restrict activities or follow medical advice. 5. Patients with inadequate bone stock or quality. 6. Patients with physical or medical conditions that would prohibit beneficial surgical outcome. 7. Use with components of other systems. 8. Reuse or multiple uses.

Rx ONLY

POTENTIAL ADVERSE EVENTS AND COMPLICATIONS As with any major surgical procedures, there are risks involved in orthopedic surgery. Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; dysphagia; dysphonia; dural tear or CSF leak; esophageal injury; worsened neurologic status; vertebral artery injury; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity. Rarely, some complications may be fatal. Potential risks identified with the use of this system, which may require additional surgery, include:  Bending, fracture or loosening of implant component(s)  Loss of fixation  Nonunion or delayed union  Fracture of the vertebra  Implant subsidence  Neurological, vascular or visceral injury  Spinal cord or nerve root injury (particularly C5) due to over-distraction  Nerve damage due to surgical trauma  Metal sensitivity or allergic reaction to a foreign body  Infection  Decrease in bone density due to stress shielding  Pain, discomfort or abnormal sensations due to the presence of the device  Bursitis  Dural leak  Paralysis  Death WARNINGS, CAUTIONS AND PRECAUTIONS The subject device is intended for use only as indicated. 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. Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone. These devices are not designed to withstand the unsupported stress of full weight or load bearing alone. Based on fatigue testing results, when using the X-Core Expandable VBR System and the X-Core Mini Cervical Expandable VBR System, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system. Careful preoperative planning, intraoperative sizing, radiographic confirmation of proper spinal segment height restoration, and intraoperative neuromonitoring are critical in avoiding spinal cord and nerve root injuries that may be caused by over-distraction. Do not over-distract the spinal segment. Careful preoperative planning and intraoperative sizing to maximize endplate coverage are important in helping avoid implant subsidence. Caution must be taken due to potential patient sensitivity to materials. Do not implant in patients with known or suspected sensitivity to the aforementioned materials. These devices can break when subjected to the increased load associated with delayed union or nonunion. Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs. If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break. Loads on the device produced by load bearing and by the patient’s activity level will dictate the longevity of the implant. Corrosion of the implant can occur. Implanting metals and alloys in the human body subjects them to a constantly changing environment of salts, acids, and alkalis, which can cause corrosion. Placing dissimilar metals (e.g., titanium and stainless steel) in contact with each other can accelerate the corrosion process, which in turn, can enhance fatigue fractures of implants. Consequently, every effort should be made to use compatible metals and alloys in conjunction with each other. When used in the cervical spine at one or two levels, the NuVasive X-Core Mini Cervical Expandable VBR System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation. Avoid excessive distraction to decrease the risk of overdistraction causing neurologic injury. When delivering the X-Core Mini Cervical Expandable VBR device, use radiographic confirmation and intraoperative neuromonitoring to reduce the risk of potential spinal cord and nerve root injuries that may be caused by over-distraction. Confirm that the height of the restored spinal segment on intraoperative radiographs is consistent with preoperative planning. Place supplemental fixation (e.g., anterior plate and/or posterior cervical screw fixation system) at the necessary levels to reduce the risk of implant subsidence and vertebral body fracture as well as the potential for implant migration. Additional posterior supplemental fixation may be required in some cases for adequate stabilization. See the supplemental fixation system instructions for use and surgical technique for instructions. All components should be final tightened per the specifications in the Surgical Technique. Implants should not be tightened past the locking point, as damage to the implant may occur. In order to ensure proper inserter/implant engagement, the inserter’s colored distal tip must face up toward the like-colored spinning sleeve of the implant. To ensure proper anatomical alignment, the rounded corners of the X-Core shape endcaps must face anterior during implant construction and placement. Care should be taken to ensure that all components are ideally fixated prior to closure. 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. Single Use/Do Not Re-Use: Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure, material degradation, potential leachables, and transmission of infectious agents.

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9400903998-EN L-2022-02

MRI Safety Information: Non-clinical testing has demonstrated that the X-CORE Expandable VBR System and the X-Core Mini Cervical Expandable VBR System devices are MR-Conditional. A patient with this device can be scanned in an MR system with the following conditions:  Static magnetic field of 1.5 Tesla (1.5T) or 3.0 Tesla (3.0T)  Maximum spatial gradient field less than or equal to 1,000 Gauss (G)/cm (10.0T/m).  Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode). Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than or equal to 6ºC after 15 minutes of continuous scanning. Caution: The RF heating behavior does not scale with static field strength. Devices which do not exhibit detectable heating at one field strength may exhibit high values of localized heating at another field strength. In non-clinical testing, the image artifact caused by the device extends radially up to 21mm and 28mm (respectively) from the device when imaged with a gradient echo pulse sequence in a 1.5T MR system and a gradient echo pulse sequence in a 3.0T MR system. Compatibility: Do not use X-CORE Expandable VBR System and the X-Core Mini Cervical Expandable VBR System with components of other systems. Unless stated otherwise, NuVasive devices are not to be combined with the components of another system. PRE-OPERATIVE WARNINGS 1. Only patients that meet the criteria described in the indications should be selected. 2. Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided. 3. Care should be used in the handling and storage of the X-Core implants. The implants should not be scratched or damaged. Implants and instruments should be protected during storage and from corrosive environments. 4. Refer to Cleaning and Sterilization Instructions below for all non-sterile parts. 5. Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient. POST-OPERATIVE WARNINGS During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments. Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications. To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques. It is important to instruct the patient in appropriate postoperative activity restrictions to minimize the risk of potential vertebral body fracture and implant migration. METHOD OF USE Please refer to the Surgical Technique for this device. PACKAGING All implant and instrument sets should be carefully examined for completeness, and for lack of damage, prior to use. Damaged packages or products should not be used, and should be returned to NuVasive. All implants provided non-sterile are single use and should be sterilized per instructions provided below. Instruments provided non-sterile can be single-use or reusable. Discard single-use instruments after use. Reusable instruments should be reprocessed using instructions provided below. All instruments provided sterile are intended for single use only. Do not use if package is opened or damaged. This product should NOT be re-sterilized. Discard single-use instruments after use. CLEANING AND DECONTAMINATION All non-sterile instruments must first be thoroughly cleaned using the validated methods prescribed in the NuVasive Cleaning and Sterilization Instructions (doc #9400896) before sterilization and introduction into a sterile surgical field. Contaminated instruments should be wiped clean of visible soil at the point of use, prior to transfer to a central processing unit for cleaning and sterilization. The validated cleaning methods include both manual and automated cleaning. Visually inspect the instruments following performance of the cleaning instructions to ensure there is no visual contamination of the instruments prior to proceeding with sterilization. If possible contamination is present at visual inspection, repeat the cleaning steps. Contaminated instruments should not be used, and should be returned to NuVasive. Contact your local representative or NuVasive directly for any additional information related to cleaning of NuVasive surgical instruments. Instruments with a “D” prefix part number (e.g. DXXXXXXX) may be disassembled. Please refer to the additional disassembly instructions for these instruments. STERILIZATION All non-sterile instruments and implants are sterilizable by steam autoclave using standard hospital practices, in addition to NuVasive’s validated parameters. In a properly functioning and calibrated steam sterilizer, effective sterilization may be achieved using the parameters prescribed in the NuVasive Cleaning and Sterilization Instructions (doc #9400896). INFORMATION To obtain a Surgical Technique Manual or should any information regarding the products or their uses be required, please contact your local representative or NuVasive directly at +1-800-475-9131. You may also email: [email protected]. The responsibility resides with the user to ensure that the most current version of the IFU is used. To obtain a paper copy of current or historical Instructions for Use, please contact your local NuVasive representative.

Rx ONLY

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