Optio-C® Anterior Cervical System

Description

The Optio-C System is composed of one Optio-C PEEK IBF Spacer, one Optio-C Anterior Cervical Plate and three Optio-C Bone Screws. The Optio-C Device is secured by an antimigration system that is designed to maintain no profile. The Optio-C System is designed to maximize fusion with a load-sharing interface and multiple implant footprints.

Indications

The Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD) is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Optio-C IBFD is composed of one Optio-C PEEK IBF Spacer, one Optio-C Anterior Cervical Plate and three Optio-C bone screws.

The Optio-C IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had 6 weeks of nonoperative treatment.

Contraindications

• Disease conditions that have been shown to be managed safely and predictably without the use of internal fixation devices are relative contraindications to the use of these devices.
• Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation.
• Severe osteoporosis is a relative contraindication because it can increase the occurrence of subsidence.
• Any entity or condition that totally precludes the possibility of fusion, such as cancer, kidney dialysis or osteopenia, is a relative contraindication.
• Obesity
• Pregnancy
• Certain degenerative disease
• Foreign body sensitivity
• The patient’s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, some patients may, because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism or drug abuse, place undue stresses on the implant.
• Metabolic disorders that can impair bone formation
• Inadequate bone stock to support the device
• Poor prognosis for good wound healing (e.g., decubitis ulcer, end-stage diabetes, severe protein deficiency and/or malnutrition)
• Knownpatientsensitivitytodevice materials (titanium alloy, Ti-6Al-4V ELI or polyetheretherketone [PEEK])
• Useintheposteriorelements(pedicles)of the cervical, thoracic or lumbar vertebrae
• Whereattemptedcorrectionexceedsthe limits of physiological conditions
• Anyconditionnotdescribedinthe indications for use

See also the WARNINGS and PRECAUTIONS section of this document.

Warnings:

• Implants and instruments should be stored in their original packaging in a dry environment, away from aggressive or oily chemicals.
• When inserting the implant, care should be taken to avoid using excessive force, which has the potential to cause damage to the implant or surrounding tissue.
• When preparing the disc space, care should be taken to ensure that an appropriate amount of bone is removed; excessive removal of bone has the potential to cause subsidence, while failing to remove enough bone has the potential to cause poor fusion.
• During screw insertion, care should be taken to avoid bone screw stripping, which has the potential to cause an unstable screw construct.
• Care should be taken when handling the flexible instruments. Specifically, the flexible tip should be maintained in the guide to prevent soft tissue damage.
• When inserting the implant, ensure a tight fit between the inserter and implant. Release distraction before drilling to prevent shifting.
• During distraction of the disc space, care should be taken to prevent over-distraction or under-distraction, which has the potential to cause irreversible damage to the patient or an unstable implant construct.
• If existing hardware is present, compatibility between the distraction pin and the existing hardware should be verified before use. When the distraction pin is used with existing hardware, extreme care should be taken to prevent damage to existing hardware.
• Potential risks identified with the use of this device system, which may require additional surgery, include:

a) Device component fracture b) Lossoffixation
c) Non-union
d) Neurologicalinjury
e) Vascularorvisceralinjur

• Do not use this product for other than labeled indications (off-label use).
• Componentsofcompetitivespinalsystems should not be used with the Optio-C Devices.

• Patientselectionshallconsiderthe following factors which are important to the success of the procedure and the performance of the device:

a) The patient’s weight. An overweight or obese patient can produce loads on the device that can lead to a loss of interbody height or failure of the device and/or the operation.

b) The patient’s occupation or activity. If the patient is involved in an occupation or activity that includes substantial walking, running, lifting or muscle strain, the resultant forces can cause loss of disc height and/or failure of the device.

c) Aconditionofsenility,mentalillness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications.

d) Certaindegenerativediseases.Insome cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopedic devices can only be considered a delaying technique or temporary relief.

e) Foreign body sensitivity. If material sensitivity is suspected, appropriate tests should be made before material selection or implantation.

f) Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures in which bone graft is used.

• Implants can break when subjected to the increased loading associated with delayed union or non-union. Spinal implants are loadsharing devices that are used to obtain an alignment until normal healing occurs. If healing is delayed or does not occur, the implant may eventually break because of fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure.

• These warnings do not include all adverse effects that can occur with surgery in general. General surgical risks should be explained to the patients before surgery.
• The Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD) is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
• The Optio-C PEEK IBF Spacer is not to be used alone.
• TheOptio-CAnteriorCervicalPlateisnotto be used alone.

It is strongly recommended that the patient be informed of the risks associated with surgical procedures and components.

• Surgical implants must never be reused. An explanted implant should never be reimplanted. Although the device appears undamaged, it may have small defects and internal stress patterns that could lead to early breakage. Reuse of a single use device that has contacted blood, bone, tissue or other body fluids can lead to patient or user injury. Risks associated with reuse of single use devices include:
  • Mechanical malfunction
  • Transmission of infectious agents
• Based on the fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, or other patient conditions that can affect the performance of the system.
• Adequately instruct the patient. Postoperative care and the patient’s ability and willingness to follow instructions are two of the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant and that physical activity and full weight bearing have been implicated in fracture. The patient should understand that an implant is not as strong as normal, healthy bone and will fracture if excessive demands are placed on it in the absence of complete bone healing. An active, debilitated or demented patient who cannot properly use weight-supporting devices may be particularly at risk during postoperative rehabilitation.
• The Optio-C IBFD device should be used only after the spinal surgeon has had training in this method of fixation and has become thoroughly knowledgeable about the spinal anatomy and biomechanics.
• The Surgical Technique Guide is not a substitute for training; it is for informational purposes only.
• Carefully read all instructions and be familiar with the Optio-C Anterior Cervical PEEK Interbody System surgical technique before use.