INDICATIONS, SAFETY, AND WARNINGS CD HORIZON SPINAL SYSTEM
The CD Horizon™ Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.
The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, Crosslink™ plates and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, Spire™ plates, and Dynalok™ bolts. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.
Certain implant components from other Medtronic spinal systems can be used with the CD Horizon™ Spinal System in non-pediatric cases. These components include TSRH™ rods, hooks, screws, plates, Crosslink™ plates, connectors, staples and washers, GDLH™ rods, hooks, connectors and Crosslink™ bar and connectors; Liberty™ rods and screws; Dynalok™ Plus and Dynalok Classic™ bolts along with rod/bolt connectors; and Medtronic multi-axial rods and screws. Note that certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so the correct components are used in the spinal construct.
CD Horizon hooks are intended for posterior use only. CD Horizon™ staples and CD Horizon™ Eclipse™ rods and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD Horizon™ 4.5mm rods and associated components may be used posteriorly.
The CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobalt-chromium-molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied warranties of merchant ability and fitness for a particular purpose or use are specifically excluded. Never use stainless steel and titanium implant components in the same construct.
Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. The CD Horizon™ Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients.
PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column.
To achieve best results, do not use any of the CD Horizon™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD Horizon™ Spinal System components should ever be reused under any circumstances.
The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.
With the exception of DDD, the CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e.scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cagefor patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use. The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a listof the Vertex™ indications of use.
Nota bene: although not absolute contraindications, conditions to be considered as potential factors for not using this device include:
All of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of potential adverse events includes
Note: additional surgery may be necessary to correct some of these potential adverse events.
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 degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of this device for any other conditions are unknown. The implants are not prostheses. In the absence of fusion, the instrumentation and/or one or more of its components can be expected to pull out, bend, or fracture as a result of exposure to every day mechanical stresses.
These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. CD Horizon™ PEEK rods are intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. This device is not a prosthesis and is not intended for standalone use.
A device that has been implanted should never be reprocessed or reused under any circumstances. Sterile packaged devices should also never be resterilized. Reprocessing or reuse may compromise the structural integrity of these implants and create arisk of contamination of the implants which could result in patient injury, illness, or death.
Warning: the safety and effectiveness of this device has not been established for use as part of a growing rod construct. This device is only intended to be used when definitive fusion is being performed at all instrumented levels.
The use of pedicle screw fixation in the pediatric population may present additional risks when patients are of smaller stature and skeletally immature. Pediatric patients may have smaller spinal structures (pedicle diameter or length) that may preclude the use of pedicle screws or increase the risk of pedicle screw malpositioning and neurological or vascular injury. Patients notskeletally mature that undergo spinal fusion procedures may have reduced longitudinal spinal growth, or may be at risk forrotational spinal deformities (the “crankshaft phenomenon”) due to continued differential growth of the anterior spine.
Other adverse events related to pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in pediatric patients. Pediatric patients may be at increased risk for device-related injury because of their smaller stature.
Consider the extent of decompression, as well as the amount of intact bone remaining on the spinous processes, when using the CD Horizon™ Spire™ plate as the sole supplemental fixation for an interbody fusion procedure.
The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many extenuating circumstances may compromise the results. This device 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 breakageof the device(s) will eventually occur.
Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and placement of the implants are important considerations in the successful utilization of the system by the surgeon. Further, the proper selection and compliance of the patient will greatly affect the results. Patients who smoke have been shown to have an increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, 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.
The implantation of pedicle screw spinal systems in pediatric patients should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system in pediatric patients because this is a technically demanding procedure presenting a risk of serious injury to the patient.
Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and placement of the implants are important considerations in the successful utilization of the system in pediatric patients.The selection of the proper size, shape, and design of the implant for each patient is crucial to the safe use of this device inpediatric patients.
Physician note: although the physician is the learned intermediary between the company and the patient, the important medical information given in this document should be conveyed to the patient.
For US Audiences Only
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
The selection of the proper size, shape, and design of the implant for each patient is crucial to the success of the procedure. Metallic surgical implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design tothe size and shape of human bones. Unless great care is taken in patient selection, proper placement of the implant, and postoperative management to minimize stresses on the implant, such stresses may cause metal fatigue and consequent breakage, bending, or loosening of the device before the healing process is complete which may result in further injury or the need to remove the device prematurely.
In cases where a percutaneous posterior approach is used, refer to the CD Horizon™ Sextant™ surgical technique. CD Horizon™ Spinal System instrumentation contains rods and implants of various diameters, which are intended to be used with device specific instruments. For self breaking plugs, always hold the assembly with the Counter Torque device. Tighten and break-off the head of the plug to leave the assembly at optimum fixation security. After the upper part of the self-breaking plug has been sheared off, further re-tightening is not necessary and not recommended. The head part should not remain in the patient. After the upper part of the self breaking plug has been sheared off, re-adjustment is not possible unless the plug is removed and replaced with a new one.
When using DTT Transverse Links, the M6 plug should be tightened between 8 and 9 Nm. (70 to 80 inch-lbs). CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column.
The physician's postoperative directions and warnings to the patient, and the corresponding patient compliance, are extremely important.
Devices may be supplied in a sterile or non-sterile form. Packages for each of the components should be intact upon receipt. Once the seal on the sterile package has been broken, the product should not be re-sterilized. If a loaner or consignment system is used, all sets should be carefully checked for completeness and all components should be carefully checked to ensure there is no damage prior to use. Damaged packages or products should not be used, and should be returned to Medtronic.
Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants used insurgery must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization. Only sterile products should be placed in the operative field. Unless specified elsewhere, these products are recommended to be steam-sterilized by the hospital using one of the sets of process parameters in Table 1.
Table 1: Sterilization cycle parameters for the US and its territories
|Method||Cycle||Temperature||Exposure time||Minimum dry time1|
|Steam||Dynamic-air-removal||270°F (132°C)||4 Minutes||30 Minutes|
|Steam||Dynamic-air-removal||275°F (135°C)||3 Minutes||30 Minutes|
Note: because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization process (e.g. temperatures, times) used for their equipment. 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 (FDA) for the selected sterilization cycle specifications (time and temperature). The sterilization cycles listed in Table 2 are not considered by the FDA to be standard sterilization cycles. *For medical facilities located outside the US and its territories, some non-US health care authorities recommend sterilization according to these parameters so as to minimize the potential risk of transmission of Creutzfeldt-Jakob disease, especially of surgical instruments that could come into contact with the central nervous system.
Table 2: Sterilization cycle parameters for medical facilities outside the US and its territories
|Method||Cycle||Temperature||Exposure time||Minimum dry time1|
|Steam||Dynamic-air-removal||273°F (134°C)||4 Minutes||30 Minutes|
|Steam||Dynamic-air-removal||273°F (134°C)||20 Minutes*||30 Minutes|
The CD Horizon™ Spinal System has not been evaluated for safety, heating, migration, or compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the CD Horizon™ Spinal System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
For product problems, contact Medtronic.
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If further information is needed or required, contact Medtronic.
©2019 Medtronic Sofamor Danek USA, Inc. All rights reserved.