Anterior Cervical Cage System
The design rationale for the CastleLoc-C Anterior Cervical Interbody Fusion Cage System is to offer surgeons an attractive alternative to current methods of treating degenerative disc disease in the cervical spine.
CastleLoc-C Anterior Cervical Interbody Fusion Cage System uses a simple, easy-to-implant threaded cage, which is indicated for single-level ACDFs.
Its tapered design provides for optimal restoration of normal cervical lordosis.
The wide range of sizes accommodates a large range of cervical anatomies.
CastleLoc-C Anterior Cervical Cage is implanted via an open anterior approach. The versatile, straightforward instrument designs allow for precise sizing of the disc space and end plate preparation. A series of sequential, color-coded instruments guide the surgeons through the procedure in a simple, intuitive manner.
CastleLoc-C Anterior Cervical Cage must be used with supplemental fixation to increase the primary stability of the implant, whenever necessary.
CastleLoc-C Anterior Cervical Cage is radiolucent allowing visualization of bone growth through the implant and the success of fusion. The bio-compatibility and mechanical qualities of PEEK-Optima® LTI have now been largely recognized for interbody applications. PEEK-Optima® LTI has elasticity close to that of bone so that there is no graft weight-bearing problem, allowing a biomechanical consistency between two spine segments.
CastleLoc-C Anterior Cervical Interbody Fusion Cage System is implanted using a reproducible operating technique. As soon as they are placed, the serrated profile of the implant ensures its self-retaining properties, until fusion takes place.
CastleLoc-C Anterior Cervical Interbody Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient’s history and radiographic studies.CastleLoc-C Anterior Cervical Interbody Fusion Cage System is used to facilitate interbody fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. CastleLoc-C Anterior Cervical Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatments prior to treatment with an intervertebral cage.
Features & Benefits
CastleLoc-C Anterior Cervical Interbody Fusion Cage System is simple to use, easy to implant, and indicated for single-level ACDFs.
- Anatomical shape : Upper Convex
- Wide Range of Sizes
- Simple Instruments for Easier and Faster Surgery
- PEEK-Optima® LTI
- Radiopaque Markers Allows for Visualization in Radiographic Images
CastleLoc-C Cervical Interbody Fusion Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with one level cervical disc disease in C3 disc to C7 disc.
CastleLoc-C Cervical Interbody Fusion Cage System is intended for use as an interbody fusion cage device and is to be used with supplemental fixation. The devices are available in a variety of sizes and configurations to accommodate anatomical variations in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA® LTl with marker pins made of titanium alloy (Ti-6Al-4V ELI).CastleLoc-C Cervical Interbody Fusion Cage System devices are designed for an anterior approach.
CastleLoc-C Cervical Interbody Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. CastleLoc-C Cervical Interbody Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using auto-graft bone. CastleLoc-C Cervical Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatments prior to treatment with an intervertebral cage.
CastleLoc-C Cervical Interbody Fusion Cage System is not intended for posterior surgical implantation. Contraindications include, but are not limited to:
- Any case needing to mix metals from different components
- Any case not described in the indications
- Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count.
- Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition
- Any patient unwilling to co-operate with postoperative instructions
- Fever or leukocytosis
- Infection, local to the operative site
- Mental Illness
- Morbid Obesity
- Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.
- Signs of local inflammation
- Suspected or documented metal allergy or intolerance
These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
Contraindications of this device are consistent with those of other spinal systems.
POTENTIAL ADVERSE EVENTS
All of the possible adverse events or complications associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of possible adverse events or complications includes, but is not limited to:
- Bone loss or decrease in bone density, possibly caused by stress shielding
- Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits, arachnoiditis, and/or muscle loss.
- Cessation of any potential growth of the operated portion of the spine.Loss of spinal mobility or function. Inability to perform the activities of daily living.
- Change in mental status
- Development of respiratory problems, e.g., pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.
- Disassembly, bending, and/or breakage of any or all of the components
- Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis
- Early or late loosening of the components. Implant migration
- Foreign body (allergic) reaction to the implants, debris, corrosion products, including metallosis, staining,
tumor formation and/or autoimmune disease
- Fracture, microfracture, resorption, damage, penetration, and/or retropulsion of any spinal bone, of the auto-graft,
or at the bone graft harvest site-at, above, and/or below the level of surgery
- Gastrointestinal complications
- Graft donor site complications including pain, fracture, infection, or wound healing problems
- Hemorrhage, hematoma, occlusion, seroma, edema, embolism, stroke, excessive bleeding, phlebitis, damage to blood
vessels, or cardiovascular system compromise.
- Wound necrosis or wound dehiscence
- Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery
- Loss of neurologial function, including paralysis (complete or incomplete), dysesthesia, hyperesthesia, anesthesia, paraesthesia, appearance or radiculopathy, and/or the development or continuation of pain, numbness, neuroma, tingling sensation, sensory loss and/or spasms
- Non-union (or pseudarthrosis); Delayed union; Mal-union
- Postoperative change in spinal curvature, loss of correction, height, and/or reduction
- Scar formation possibly causing neurological compromise around nerves and/or pain
- Subsidence of the device into vertebral body(ies)
- Tissue or nerve damage, irrigation, and/or pain caused by improper positioning and placement of implants or instruments
NOTE : Additional surgery may be necessary to correct some of these anticipated adverse events.
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other patient conditions may compromise the results.CastleLoc-C Cervical Interbody Fusion Cage System must be used with the CastleLoc-P Anterior Cervical Plate Screws to augment stability. Use of this product without auto-graft may 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 eventually occur.
Preoperative and operating procedures, including knowledge of surgical techniques, proper selection and placement of the implant and good reduction are important considerations in the success of surgery.
Never reuse an internal fixation device under any circumstances. Even when a removed device appears undamaged, it may have small defects or internal stress patterns that may lead to early breakage. Damage of the thread will reduce the stability of the instrumentation.
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, and/or alcohol abuse patients are also poor candidates for spine fusion.
CastleLoc-C Cervical Interbody Fusion Cage System has not been evaluated for safety and compatibility in the MR environment.
CastleLoc-C Cervical Interbody Fusion Cage System has not been tested for heating or migration in the MR environment.
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
CAUTON : FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
CHOICE OF IMPLANTS
The selection of the proper size, shape and design of the implant for each patient is crucial to the success of the procedure.
Plastic polymer implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the 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 material 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.
- Only patients that meet the criteria described in the indications should be selected.
- Patient conditions and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.
- Care should be used in the handling and storage of the implant components. The implants should not be scratched or damaged. Implants and instruments should be protected during storage especially from corrosive environments.
- Further information on the use of this system will be made available on request.
- Since mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment and should personally assemble the devices to verify that all parts and necessary instruments are present before the surgery begins.
- The type of construct to be assembled for the case should be determined prior to beginning the surgery. An adequate inventory of implant sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used.
- Unless sterile packaged, all parts should be cleaned and sterilized before use. Additional sterile components should be available in case of an unexpected need.
- The instructions in any available applicable surgical technique manual should be carefully followed.
- At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss of neurological functions.
- Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
- To assure proper fusion below and around the location of the instrumentation, auto-graft should be used. Auto-graft must be placed in the area to be fused and graft material must extend from the upper to the lower vertebrae being fused. When using the CastleLoc-C Cervical Interbody Fusion Cage System, auto-graft should be used.
- Bone cement should not be used since this material will make removal of the components difficult or impossible. The heat generated from the curing process may also cause neurologic damage and bone necrosis.
The physician’s postoperative directions and warnings to the patient and the corresponding patient compliance, are extremely important.
- Detailed instructions on the use and limitations of the device should be given to the patient. If partial weight bearing is recommended or required prior to firm bony union, the patient must be warned that bending, loosening or breakage of the device are complications which can occur as a result of excessive weight bearing or muscular activity. The risk of bending, loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be increased if the patient is active, or if the patient is debilitated, demented or otherwise unable to use crutches or other weight supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal position.
- To allow the maximum chances for a successful surgical result: the patient or device should not be exposed to mechanical vibrations that may loosen the device construct. The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient should be advised not to smoke or consume excess alcohol during the bone healing process.
- The patients should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this permanent physical restriction in body motion.
- Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on the implant. By the mechanism of fatigue these stresses can cause eventual bending, loosening, or breakage of the device. It is important that immobilization of the union is established and confirmed by roentgenographic examination. Where there is a non-union, or if the components loosen, bend, and/or break, the device should be revised and/or removed immediately before serious injury occurs.
- Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.
Components should only be accepted if received with the factory packaging and labeling intact. All sets should be carefully inspected before use. In particular, check for completeness of the set and integrity of the components and/or instruments. Any damaged packaging and/or product must be returned to L&K BIOMED.
Instruments must always be examined by the user prior to use in surgery. Examination should be thorough, and in particular, should take into account a visual and functional inspection of the working surfaces, pivots, racks, spring or torsional operation, cleanliness of location holes or cannulations, and the presence of any cracks, bending, bruising or distortion, and that all components of the instrument are complete.
Never use instruments with obvious signs of excessive wear, damage, or that are incomplete or otherwise unfunctional.
STORAGE AND HANDLING
CastleLoc-C Cervical Interbody Device should be stored in a dry environment, protected from direct sunlight and at an ambient temperature in their original packaging.
CLEANING AND STERILIZATION
Implants are supplied non-sterile and are for single use only. So all implants used in surgery must be sterilized by the hospital prior to use. Otherwise, Instruments are supplied non-sterile and may be re-used. Instruments must be thoroughly cleaned prior to sterilization. Trained personnel must perform cleaning and mechanical inspection prior to sterilization.
Unless just removed from an unopened L&K BIOMED package, all instruments and implants must be disassembled (if applicable) and cleaned using neutral cleaners before sterilization and introduction into a sterile surgical field or (if applicable) return of the product to L&K BIOMED.
Use of corrosive products and/or instruments including abrasive sponges and metal brushes should be avoided. Visually inspect the devices under normal room lighting condition to verify all foreign debris has been removed. Verify that the instruments are in operation condition.