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About this product

Division: Spine
Category: Interbody Fusion

The CONCORDE® Inline Lumbar Interbody System completes our CONCORDE Interbody Cage Platform for posterior MIS and open lumbar procedures.  The system provides a posterior approach interbody fusion solution with a front to back lordotic cage option to address proper spinal alignment.

Made of a proprietary material of Carbon Fibre Reinforced Polymer, it has large areas for bone graft placement within the cage which allows the design to be a load-sharing device with 33% more bone graft area.*  This open architecture also provides for good graft to endplate surface contact.

The bulleted nose of the implant creates a self-distracting device that is designed to address collapsed disc spaces minimizing damage to endplates.  With an option of a 5° front to back lordotic cage and shorter lengths the system is optimised for the PLIF procedure.

*Data on file at DePuy Synthes Spine.

 

Intended Use

The CONCORDE Inline System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via a PLIF or TLIF using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Synthes Spine supplemental internal fixation products.

The CONCORDE Inline System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Synthes Spine supplemental internal fixation products.

CONTRAINDICATIONS:
1. Use of these systems is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials.
2. Severe osteoporosis or osteopenia may prevent adequate fixation and thus preclude the use of these or any other orthopaedic implants.
3. Conditions that may place excessive stresses on bone and implants, such as severe obesity, pregnancy or degenerative diseases, are relative contraindications. The decision to use these devices in such conditions must be made by the physician taking into account the risks versus the benefits to the patient.
4. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure.
5. Prior fusion at the level(s) to be treated.
6. Any condition not described in the Indications for Use.

WARNINGS: In the USA, this product has labelling limitations. See package insert for complete information.

1. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory anterior column support is increased by the selection of the proper size device. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape and strength of implants. Internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing.

2. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation appliances are load sharing 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 due to material 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.

3. MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel, accelerate the corrosion process of stainless steel and more rapid attack occurs. The presence of corrosion often accelerates fatigue fracture of implants. The amount of metal compounds released into the body system will also increase. Internal fixation devices, such as rods, hooks, wires, etc., which come into contact with other metal objects, must be made from like or compatible metals.

PRECAUTIONS:

1. SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted implant should never be reimplanted. Even though a device appears undamaged, it may have small defects and internal stress patterns that may lead to early breakage. Reuse can compromise device performance and patient safety. Reuse of single use devices can also cause cross-contamination leading to patient infection.

2. Correct Handling of the Implant is Extremely Important. Polymer/carbon-fibre implants are designed to support physiologic loads. Excessive torque, when applied to long-handle insertion tools, can cause splitting or fracture of the polymer/carbon-fibre implants. When a polymer/carbon-fibre implant is impacted or hammered into place, the broad surface of the insertion tool should be carefully seated fully against the implant. Impaction forces applied directly to a small surface of the implant could cause fracture of the implant. Split or fractured implants should be removed and replaced. Implants can break when subjected to the increased loading associated with delayed union or non-union.

3. Removal of Supplemental Fixation After Healing. If the supplemental fixation is not removed following the completion of its intended use, any of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain; (2) Migration of implant position resulting in injury; (3) Risk of additional injury from postoperative trauma; (4) Bending, loosening, and/or breakage, which could make removal impractical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device; (6) Possible increased risk of infection; and (7) Bone loss due to stress shielding. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implants. Implant removal should be followed by adequate postoperative management to avoid refracture. If, for example, the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risks involved with a second surgery.

4. Adequately Instruct the Patient. Postoperative care and the patient’s ability and willingness to follow instructions are among the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implants. The patient should be encouraged to ambulate to tolerance as soon as possible after surgery, and instructed to limit and restrict lifting and twisting motions and any type of sports participation until the bone is healed. The patient should understand that implants are not as strong as normal healthy bone and could loosen, bend and/or break if excessive demands are placed on it, especially in the absence of complete bone healing. Implants displaced or damaged by improper activities may experience migration and damage nerves or blood vessels.

5. Cauterization Near the Implant: When performing cauterization around an implant, care should be taken to avoid contact with the implant.

6. Patients with Previous Surgery. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery.

 

Features & Benefits

 

  Features Benefits
  • Bulleted nose cage
  • Allows access to collapsed spaces with minimal disruption of end plates
 
  • CFRP material
  • Creates a strong base material that allows for an open implant design
  • Robust size offering
  • Allows for varying patient anatomy
  • Lordotic trials
  • Allow for precise cage orientation and size measurement
  • Tantalum markers
  • Three markers allows for verification of placement and positioning

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Please refer to the surgical technique guide or package inserts if included for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative .
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