ZEUS INTERVERTEBRAL BODY FUSION DEVICES Instructions for Use

5.

Scoliosis

6.

Active infection

7.

Allergy to Titanium (Ti-6Al-4V), tantalum or PEEK

8.

Signs of local inflammation

9.

Fever or leukocytosis

10. Morbid obesity 11. Pregnancy 12. Mental illness 13. Suspected or documented allergy or intolerance to composite materials. 14. Any case not needing a fusion. 15. Any case not described in the indications. 16. Any patient unwilling to cooperate with postoperative instructions. 17. Patients with a known hereditary or acquired bone friability or calcification problem should not be considered for this type of surgery. 18. These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth. 19. Spondylolisthesis unable to be reduced to Grade 1. 20. Any case where the implant components selected for use would be too large or too small to achieve a successful result. 21. Any case that requires the mixing of metals from two different components or systems. 22. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality. 23. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance. 24. Prior fusion at the level to be treated. 25. Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count. Additional contraindications for the Zeus-L Device include but are not limited to: •

Symptomatic level at L5-S1

•

Lumbar deformities with more than 30° of rotation

•

Retroperitoneal scarring on both left and right sides (e.g., due to abscess or prior surgery)

•

Need for direct nerve decompression through the same approach.

WARNING Implants provided sterile are sterilized through gamma irradiation. Do not re-sterilize implants provided sterile. Devices provided non-sterile must be cleaned and sterilized before use. Implants may be reprocessed prior to use and must be sterilized before use. Validated sterilization cycle parameter protocols are noted in the STERILIZATION section of this insert. Implants that have come in direct contact with a patient or bio-contaminants should be disposed of. Some instruments may be sharp, depending on their intended use. Care should be taken in handling such instruments to avoid injury to the user or patient. A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where

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many extenuating circumstances may compromise the results. System components are temporary implants used for the correction and stabilization of the spine. Devices are intended to be used to augment the development of a spinal fusion by providing temporary stabilization. Devices are not intended to be the sole means of spinal support. Use of these products without a bone graft or in cases that develop into a non-union will not be successful. No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly and/or breakage of the device(s) will occur. Implantation of devices should be performed only by experienced surgeons with training in the use of spinal devices. This is a technically demanding procedure presenting a risk of serious injury to the patient. Preoperative and operating procedures including knowledge of surgical techniques, proper reduction, and proper selection and placement of the implant are important considerations in the successful utilization of this device by the surgeon. Further, the proper selection and compliance of the patient will greatly affect the results. The physician should consider the levels of implantation, patient weight, patient activity level, and all other patient conditions that may have an impact on the performance of this device. Patients who smoke have been shown to have an increased incidence of non-union. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion. Patients with poor muscle and bone quality and/or nerve paralysis are also poor candidates for spine fusion. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery. Physician Note: The physician is the learned intermediary between the company and the patient. The indications, contraindications, warnings, and precautions given in this document must be conveyed to the patient. PREOPERATIVE MANAGEMENT 1. The surgeon should consider for surgery only those patients indicated for the use of this device. 2. The surgeon should not consider for surgery those patients contraindicated for the use of this device. 3. The surgeon should have a complete understanding of the device’s indications, contraindications, and applications. 4. The surgeon should have a complete understanding of the function and limitations of each implant and instrument. 5. Device components should be received and accepted only in packages that have not been damaged or tampered with. Components must be carefully handled and stored in a manner that prevents scratches, damage, and corrosion. 6. All implants and instrument should be inspected for wear and tear prior to use. Devices presenting damage such as cracks, corrosion, bends etc. should not be used. Compromised devices should be segregated and be returned to Spinal Elements. 7. The type of implant to be used for the case should be determined prior to beginning the surgery. 8. All instruments and implants should be processed and sterilized prior to use. INTRAOPERATIVE MANAGEMENT 1. Caution should be taken in handling the implants. Damage to the implants may affect their performance. 2. Extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss of neurological functions. 3. Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.

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4. Implants should be attached to the corresponding inserter such that they are fully seated on the inserter. Care should be taken not to over-tighten the implant to the inserter. 5. Implants should not be axially rotated with the inserter once they have been implanted. This may lead to damage of the implant and/or the inserter. 6. Whenever possible or necessary, an imaging system should be utilized to facilitate surgery. 7. Implants should not be reused under any circumstances. POSTOPERATIVE MANAGEMENT Postoperative management by the surgeon, including instruction and warning to and compliance by the patient, of the following is essential: 1. The patient should have a complete understanding of and compliance with the purpose and limitations of the implant devices. 2. Postoperative patients should be instructed to limit activity as determined by their surgeon. 3. Retrieved implants should be properly disposed of and are not to be reused under any circumstances. 4. Contaminated instruments must be cleaned promptly after use per instructions noted in the Cleaning Instruction section of this insert in order to prevent drying and ensure an effective cleaning. MAGNETIC RESONANCE ENVIRONMENT Zeus Intervertebral Body Fusion Devices System have not been evaluated for safety and compatibility in the MR environment. They have not been tested for heating, migration, or image artifact in the MR environment. The safety of the device in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. POSSIBLE ADVERSE EVENTS 1. Early or late loosening of any or all of the components. 2. Disassembly, bending, and/or breakage of any or all of the components. 3. Loss of fixation (implant migration). 4. Foreign body (allergic) reaction to implants. 5. Postoperative change in spinal curvature, loss of correction, height, and/or reduction. 6. Infection. 7. Dural tears, persistent CSF leakage, meningitis. 8. Loss of neurological function including paralysis (partial or complete), radiculopathy, and/or the development or continuation of pain, numbness, spasms, or sensory loss. 9. Cauda equina syndrome, neurological deficits, paraplegia, reflex deficits, irritation, and/or muscle loss. 10. Loss of bladder control or other types of urological system compromise. 11. Scar formation possibly causing neurological compromise or compression around nerves and/or pain. 12. Fracture, micro-fracture, resorption, damage, or penetration of any spinal bone. 13. Soft tissue injury, vertebral endplate injury, vascular or visceral injury. 14. Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery. 15. Non-union (pseudo-arthrosis), delayed union, mal-union. 16. Cessation of any potential growth of the operated portion of the spine. 17. Loss of or increase in spinal mobility or function. 18. Inability to perform the activities of daily living. 19. Death. Additional surgery may be necessary to correct the occurrence of some of these possible adverse events. SINGLE 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, serious injury, transmission of infectious agents and death. All implants are single use.

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STERILITY All devices provided sterile have been gamma irradiation sterilized and are for single use only. Do not re-sterilize sterile devices. All devices provided non-sterile must be sterilized prior to use. Implants and instruments provided sterile will be clearly labeled as such in an unopened sterile package provided by Spinal Elements. SHELF LIFE The product expiration date is indicated by the hourglass symbol on the product label. Caution: Do not use sterile devices if the packaging providing the sterile barrier has been compromised. CLEANING AND MAINTENANCE GENERAL INFORMATION Spinal Elements’ instruments are manufactured from various stainless steels, aluminums, and polymers. All materials used have a history of use in such instruments. All devices provided non-sterile must be cleaned and sterilized prior to use. Do not clean devices provided sterile. CLEANING AND MAINTENANCE Devices must be free of packaging material prior to cleaning. Cleaning, maintenance and mechanical inspection must be performed by hospital personnel trained in the general procedures involving contaminant removal. Only neutral pH cleaners or detergents labeled for use in cleaning medical devices should be used for cleaning components. Only lubricants that are intended for use on surgical instruments should be used to lubricate instruments. Follow directions from the manufacturer of lubricating and cleaning agents regarding handling, concentration, and use of such agents. Cleaning instructions are provided in accordance with recognized standards and regulations and are intended to supplement a hospital’s existing device cleaning and disinfecting protocol. Contaminated devices should be wiped clean of visible soil at the point of use prior to transfer to a central processing unit for cleaning and sterilization. Contaminated devices must be cleaned promptly after use per the instructions provided in this insert to minimize drying and ensure an effective cleaning. Use clean flowing water and disposable wipes to remove excess soil. Reprocess instruments as soon as possible to prevent body fluid and tissue from drying on instruments prior to cleaning. Disassemble all components to provide maximum exposure for cleaning. All devices must be processed manually prior to automated cleaning. Cleaning agents with chlorine or chloride as an active ingredient are corrosive to stainless steel and should not be used. Saline solution has a corrosive effect on stainless steel and should not be used. Use only neutral pH cleaning agents and detergents. Caution: Automated washer/disinfector systems are not recommended as the sole cleaning method for surgical instruments. Automated cleaning may not be effective. A thorough, manual cleaning process is recommended. An automated system may be used as a follow-up method to manual cleaning. AUTOMATED CLEANING INSTRUCTIONS All devices must be processed manually prior to automated cleaning. Follow the instructions below for the manual and automated washing. PRE-AUTOMATED WASHER: MANUAL CLEANING 1. Immerse and soak for a minimum of five (5) minutes in enzymatic detergent at <43°C. 2. Immerse in Endozime® AW Plus enzymatic detergent (or equivalent neutral pH enzymatic cleaner) according to manufacturer recommendations and clean thoroughly for at least 14 minutes at <43°C. Scrub all external surfaces with a soft bristle brush until all visible soil has been removed. It is important to make sure that areas of concern with complex or hidden surfaces are effectively cleaned. Use a small diameter brush to clean cannulation holes. Inspect for visible soil on exposed surfaces.

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3. Rinse thoroughly for two (2) minutes with warm demineralized water. (Purified water at 27°-44°C) AUTOMATED CLEANING 4. Transfer the instruments into the automated washer for processing. Position the instruments to allow for proper drainage. Ensure the instruments stay in place and do not touch or overlap so that the design features are accessible for cleaning and do not retain liquid. Process per the cycle below. These are minimum validated parameters: Phase

Recirculation Time

Water Temp

Detergent Type (if applicable)

Pre-wash

300 seconds

Cold tap water

N/A

Wash 1

300 seconds

65.5°C

Wash 2

300 seconds

65.5°C

PURW Rinse Drying

10 seconds 7 minutes

82.2°C 115.5°C

Endozime AW Plus or equivalent per manufacturer’s instructions Endozime AW Plus or equivalent per manufacturer’s instructions N/A N/A

5. If needed, dry devices using a clean lint-free cloth. Pressurized air (20psi) may be used to assist in drying. 6. Visually examine devices to ensure all visible soil has been removed. 7. Once instruments pass visual inspection, reassemble devices that come apart for cleaning. MANUAL CLEANING INSTRUCTIONS Follow the instructions listed below for manual cleaning prior to sterilization. 1. 2.

3. 4.

Immerse and soak for a minimum of five (5) minutes in enzymatic detergent at <43°C. Immerse in Endozime® AW Plus enzymatic detergent (or equivalent neutral pH enzymatic cleaner) according to manufacturer recommendations and clean thoroughly for at least 14 minutes at <43°C. Scrub all external surfaces with a soft bristle brush until all visible soil has been removed. It is important to make sure that areas of concern with complex or hidden surfaces are effectively cleaned. Use a small diameter brush to clean cannulation holes. Inspect for visible soil on exposed surfaces. Rinse thoroughly for two (2) minutes with warm distilled, de-ionized, or reverse osmosis water. (27°-44°C). Allow instrument to air dry in a clean area. Blow lumens with clean air using filtered air source or syringe.

Carefully inspect each device to ensure that all visible blood and soil have been removed. Inspect lumens to confirm that all foreign material has been removed. Visually inspect for damage and/or wear. Note: If any damage or wear is noted that impairs the function of the instrument, contact your Spinal Elements representative for a replacement. STERILIZATION All devices provided non-sterile must be sterilized before use. Non-sterile implants and instruments should be autoclave sterilized using one of the following validated cycle parameters. Do not re-sterilized devices provided sterile. Visually inspect all components for any remaining debris prior to sterilization. The Zeus system components provided non-sterile should be autoclave sterilized using the sterilizer manufacturer’s instructions and the institution’s procedures for ensuring sterility. The sterilization cycle should occur in a calibrated autoclave.

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Cycle Type

Steam

Gravity Displacement

Sterilization Temperature 270°F (132°C)

Steam

Pre-vacuum

Rigid Container

Steam

K-Wire Caddy

Steam

Wrapped

Method

Exposure Time

Dry Time

15 minutes

45 minutes

270°F (132°C)

10 minutes

60 minutes

Pre-vacuum

270°F (132°C)

4 minutes

30 minutes

Pre-vacuum

270°F (132°C)

4 minutes

20 minutes

*Note: Rigid containers must have a minimum of 2 filters and require a 30 minute cooldown period post sterilization. Sterilization parameters were validated per ANSI/AAMI/ISO 17665-1: 2006. Sterilization of Health Care Products – Moist Heat – Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices and ANSI-AAM ST 79 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities. These parameters were validated to a sterility assurance level (SAL) of 10-6. The Gravity Displacement, 270°F (132°C), 15-minute and Pre-Vacuum, 270°F (132°C), 10minute sterilization cycles are not considered by the Food and Drug Administration to be a standard sterilization cycle. It is the end user’s responsibility to use only sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization cassettes) that have been cleared by the Food and Drug Administration for the selected sterilization cycle specifications (time and temperature). Information

h g M Y

IK

Catalog Number

MAT Material

Batch Code

QTY Packaged Quantity

Manufacturer

N Date of Manufacture D Do Not Re-Use

Caution, Consult Accompanying Documents Sterilized using irradiation

H

Use-by date

Device Not Sterile Prescription Only

i

Instruction for Use are provided electronically at ifu.spinalelements.com

© 2019 Spinal Elements Inc. Patent: patent.spinalelements.com For additional information regarding any of Spinal Elements’ devices, please contact Spinal Elements, Inc. Customer Service at (760) 607-0121. CAUTION: Federal Law (USA) restricts these devices for sale by or on the order of a physician.

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