LOTUS POSTERIOR CERVICAL / THORACIC SPINAL System Instructions for Use

temporary stabilization. This system is not intended to be the sole means of spinal support. Use of this product 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. Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are: significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5S1 vertebra; degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor; and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. Implantation of the device should be performed only by experienced spinal surgeons with specific training in the use of this device. 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 who have had previous spinal surgery at the level(s) to be treated may have a worse clinical outcome compared to those without previous surgery at the levels to be treated. Note: Components of this system should not be used in conjunction with other systems unless specifically specified in this package insert. 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. MAGNETIC RESONANCE ENVIRONMENT The Lotus Posterior Cervical/Thoracic Spinal System has not been evaluated for safety and compatibility in the MR environment. It has 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. 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. Use of cross sectional imaging (i.e., CT and/or MRI) for posterior cervical screw placement is recommended due to unique risks in the cervical spine. The use of planar radiographs alone may not provide the necessary imaging to mitigate the risk of improper screw placement. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement as necessary. 6. Device components should be received and accepted only in packages that have not been damaged or tampered with. Damaged implants and/or instruments should not be used. All implants and instruments should be inspected prior to use. Components must be carefully handled and stored in a manner that prevents scratches, damage, and corrosion. 7. The type of implant to be used for the case should be determined prior to beginning the surgery. 8. All instruments should be cleaned and sterilized prior to use. INTRAOPERATIVE INSTRUCTIONS 1. Extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss of neurological functions. 2. Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel. 3. 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. 4. Whenever possible or necessary, an imaging system should be utilized to facilitate surgery. 5. Caution should be taken in handling the implants. Damage to the implants may affect their performance. 6. Implants should not be reused under any circumstances.

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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 the instructions noted in the CLEANING AND MAINTENANCE section of this insert in order to prevent drying and ensure an effective cleaning. POSSIBLE ADVERSE EFFECTS 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. Post-operative 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. Implants that have directly come in contact with the patient or bio-contaminants should be discarded. Separate inserts for implants from the instrument tray prior to and during any processing. 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. CLEANING AND MAINTENANCE All devices must be free of packaging material prior to sterilization. All instruments must be free of bio-contaminants prior to sterilization. Implants exposed to bio-contaminants should be disposed of. 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 the 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. AUTOMATED CLEANING INSTRUCTIONS INS-PCT

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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. Disassemble all instruments that come apart for cleaning. 2. Rinse under running tap water to remove gross contamination. Use a syringe, wire guide and/or pipe cleaner (as appropriate to the presented cleaning challenge) to push debris out of lumens/cannulations or other hard to reach areas. Pay special attention to lumens of the external shafts of disassembled instruments. 3. Prepare Enzol® (or equivalent neutral or mild pH enzymatic cleaner) according to manufacturer recommendations using warm tap water. Fully immerse devices in the enzymatic cleaner solution and allow to soak for a minimum of 1 minute. While soaking, actuate the instruments through a full range of motion (as appropriate) to allow complete penetration of the cleaning solution. Instruments that do not disassemble may require additional soaking. 4. After the soak, remove the instruments and wipe any soil or debris using a disposable towel. Then, place the instruments into a fresh batch of enzymatic cleaning solution using warm water. Scrub the entire surface of the devices with a soft bristle brush paying particular attention to hard to reach areas such as mated surfaces. A syringe, wire guide, and/or pipe cleaner should be used to aid in cleaning lumens/cannulations or other hard to reach areas. A minimum of 60ml of detergent should be used when flushing lumens and cannulations. Ensure no soil is visible in the rinse stream. 5. Remove from enzymatic cleaner solution and rinse with reverse osmosis or de-ionized (RO/DI) water for a minimum of 30 seconds to remove any residual cleaner solution. Thoroughly and aggressively flush lumens, holes and other hard to reach areas with a minimum of 60ml of water. 6. Prepare Prolystica® (or equivalent neutral pH detergent) according to manufacturer recommendations using warm tap water in an ultrasonic bath. Fully immerse into the sonication bath and sonicate for a minimum of 10 minutes. 7. Remove from the detergent solution and rinse by agitating and actuating in RO/DI water for a minimum of 30 seconds to remove any residual detergent and until no sign of soil is seen in the rinse stream. While rinsing, thoroughly and aggressively flush lumens, holes and other hard to reach areas with a minimum of 60ml of water. AUTOMATED CLEANING 8. Transfer the instruments into the washer for processing. Position the instruments to allow for proper drainage. Process per the cycle below. These are minimum validated parameters: Phase Recirculation Time Water Temp Detergent Type (if applicable) Pre-wash 2 minutes Cold tap water N/A Enzol or equivalent per Enzyme Wash 2 minutes Hot tap water manufacturer’s instructions Prolystica or equivalent per Wash 2 minutes 65.5°C manufacturer’s instructions PURW Rinse 2 minutes 43°C N/A Drying 15 minutes 90°C N/A 9. If needed, dry devices using a clean lint-free cloth. Pressurized air (20psi) may be used to assist in drying. 10. Visually examine devices to ensure all visible soil has been removed. 11. Once instruments pass visual inspection, reassemble devices that come apart for cleaning. 12. After cleaning, an instrument lubricant (i.e. Steris Hinge-Free® or equivalent) should be applied to moving devices to maintain fluid movement between components. Pay special attention to the instruments called out in system specific sections. MANUAL CLEANING INSTRUCTIONS Follow the instructions listed below for manual cleaning prior to sterilization. 1. The screwdriver sleeve and rod holder should be disassembled before cleaning by compressing the button labeled “Release for Cleaning” and removing the internal shaft. Follow the cleaning instructions listed below, paying special attention to the lumens of the external shafts and sleeves of disassembled instruments. 2. Rinse under running tap water to remove gross contamination. Use a syringe, wire guide, and/or pipe cleaner (as appropriate to the presented cleaning challenge) to push debris out of lumens/cannulations or other hard to reach areas. Pay special attention to the lumens of the external shafts of disassembled instruments. 3. Prepare Enzol (or equivalent neutral pH enzymatic cleaner) according to manufacturer recommendations using warm tap water. Fully immerse devices in the enzymatic cleaner solution and allow to soak for a minimum of 20 minutes. After the soak, scrub devices with a soft bristle brush paying particular attention to hard to reach areas such as mated surfaces. A syringe, wire guide, and/or pipe cleaner should be used to aid in cleaning lumens/cannulations or other hard to reach areas. A minimum of 60ml of detergent should be used when slushing lumens and cannulations. 4. Remove from enzymatic cleaner solution and rinse with reverse osmosis/de-ionized (RO/DI) water for a minimum of three minutes to remove any residual cleaner solution. Thoroughly and aggressively flush lumens, holes and other hard to reach areas with a minimum of 60ml of water. 5. Prepare Prolystica (or equivalent neutral pH detergent) according to manufacturer recommendations using warm tap water in an ultrasonic bath. Fully immerse into the sonication bath and sonicate for a minimum of 10 minutes. INS-PCT

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6. Remove from the detergent solution and rinse with RO/DI water for a minimum of three minutes to remove any residual detergent and until no sign of soil is seen in the rinse stream. Thoroughly and aggressively flush lumens, holes and other hard to reach areas with a minimum of 60ml of water. 7. Repeat Steps 5 and 6. 8. Dry devices using a clean lint-free cloth. Pressurized air (20psi) may be used to assist in drying. 9. Visually examine devices to ensure all visible soil has been removed. 10. After cleaning, an instrument lubricant (i.e. Steris Hinge-Free® or equivalent) should be applied to moving devices to maintain fluid movement between components. 11. All disassembled instruments should be reassembled by depressing the “Release for Cleaning” button and reengaging the outer shaft.

Rigid Wrapped Container

STERILIZATION All implants and instruments are provided non-sterile and must be sterilized before use. Non-sterile implants and instruments should be autoclave sterilized using one of the following validated cycle parameters. Exposure Time

Dry Time

Gravity Displacement

Sterilization Temperature 270°F (132°C)

15 minutes

45 minutes

Steam

Pre-vacuum

270°F (132°C)

10 minutes

60 minutes

Steam

Pre-vacuum

270°F (132°C)

4 minutes

30 minutes

Method

Cycle Type

Steam

*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. This sterilization cycle is 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

MAT Material h Catalog Number QTY Packaged Quantity g Batch Code M Manufacturer N Date of Manufacture Consult Y Caution, D Do Not Re-Use Accompanying Documents

d Device Not Sterile Prescription Only

i

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

© 2019 Spinal Elements Inc. Patents: 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 to sale by or on the order of a physician.

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