Durango® ALIF System

The Durango System is a modular, integrated plate and interbody system for anterior lumbar interbody fusion. The plate component is available in three configurations, with different screw positions and angles to tailor the implant to the patient’s anatomy and fixation demand. Each configuration offers four screws to maximize fixation while reducing the plate profile and accounting for patient anatomy.

 

Zero-Plate

  • Flush with the anterior cortex to avoid interference with the great vessels
  • 30° screw angles facilitate screw placement and purchase into the endplates of the vertebral bodies

 

Half-Plate

  • Multiple screw positions and plate orientations to provide options to avoid soft tissues 
  • Low screw angle allows straight instruments to be used in the L5 vertebral body

 

Full-Plate

  • Four low angle screws engaging the anterior cortex provide additional stability 
  • Very low-profile anterior lumbar plate

 

Indications for Use

When used as a lumbar intervertebral body fusion device, the Durango system is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Durango system is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Zimmer Biomet Spinal Fixation System. The Durango stand-alone interbody implants, when used with the integrated fixation screws, do not require use of supplemental fixation.

Contraindications

Contraindications may be relative or absolute. The choice of a particular device must be carefully weighed against the patient’s overall evaluation. Circumstances listed below may reduce the chance of a successful outcome.

Contraindications include, but are not limited to:

  • Allergy to PEEK-OPTIMA, titanium or cobalt chrome alloys, or foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to implantation.
  • Known or suspected infection/immune system incompetence. Acute or chronic infectious diseases of any etiology or localization.
  • Any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, active infection at the site or certain metabolic disorders affecting osteogenesis.
  • Morbid Obesity. An overweight or obese patient can produce loads on the spinal system, which can lead to failure of the fixation of the device or failure of the device itself.
  • Any neuromuscular deficit which places an unusually heavy load on the device during the healing period.
  • Open Wounds.
  • Pregnancy.
  • Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of the white blood count (WBC), or a marked left shift in the WBC differential count.
  • Any case requiring the mixing of components from two different systems.
  • Any case requiring the mixture of stainless steel with titanium, or stainless steel with cobalt chrome implant components.
  • Fever or leukocytosis.
  • Signs of local infection or inflammation.
  • Previous history of infection.
  • Prior fusion at the level to be treated.
  • Alcoholism or heavy smoking.
  • Senility, mental illness or substance abuse, of a severity that the patient may ignore certain necessary limitations and precautions in the use of the implant, leading to failure or other complications.
  • Any patient unwilling to follow postoperative instructions.
  • Inadequate tissue coverage over the operative site.

Possible Complications

Possible complications specific to the device may include:

  • Early or late implant bending, breakage, failure, loosening or movement/migration
  • Bone fracture
  • Allergic reaction to implant material
  • Other general complications associated with any spinal surgical procedure may include: Non-union or delayed union, pseudoarthrosis; pain; second surgery; bleeding; infection, early and late; tissue or nerve damage, including dural tears or other neurological problems; incisional complications; scar formation; damage to blood vessels and cardiovascular system compromise; changes in mental status; damage to internal organs and connective tissue; complications due to the use of bone grafting, including graft donor site complications; respiratory problems; reactions to anesthesia and/or death.

Warnings

Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes than previous surgical outcomes. The risk of a device expulsion and migration is higher without the use of integrated fixation screws as indicated.

Precautions

  • The Durango implants are for single use only. Never reuse any implant even if it appears unmarked or undamaged. Reuse of the implant components may result in reduced mechanical performance, malfunction, or failure of the device. Any implant implanted and then removed must be discarded. Use only new implants for each case. 
  • Only experienced spinal surgeons should perform the implantation of this system with specific training in the use of vertebral implants. The surgical procedure is technically demanding and presents a risk of serious injury to the patient.
  • The Durango system is intended to be used only by surgeons specialized in spinal surgery and having thorough knowledge of vertebral anatomy, regional vertebral morphology, and the biomechanical principles of the spine. It is advised that the surgeon also be thoroughly familiar with the surgical techniques relative to the use of the device.
  • Based on the fatigue testing results, the physician/surgeon must consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact on the performance of the system.
  • Risks associated with neurosurgery, general surgery, orthopedic surgery, and the use of general anesthesia should be explained to the patient prior to surgery. It is recommended that the advantages and disadvantages of using implants, as well as alternative treatment methods, are explained to the patient.
  • Preoperatively: The surgeon must be fully conversant with all aspects of the surgical technique and know the indications and contra-indications of this type of implant. The surgeon must have acquainted himself before the operation with the specific technique for insertion of the product, which is available from the manufacturer. As part of the preoperative examination, the surgeon must check that no biological, biomechanical or other factors will affect the correct conduct of the operation and the postoperative period. An appropriate range of implant sizes must be available at the time of the operation.
  • Intraoperatively: The correct selection of the type and size of implant appropriate to the patient and the positioning of the implant are extremely important.
  • Postoperatively: Patients must be informed of the precautions to be taken in their everyday life to guarantee a maximum implant service life. It is recommended that regular postoperative follow-up is undertaken to detect early signs of failure of the implants and to consider the action to be taken. Deterioration of the device after bone consolidation cannot be considered to constitute a dysfunction or deterioration in the characteristics of the implants. The implant can be removed after bony healing.
  • Correct selection and placement of the implants is extremely important. Implant selection must be based upon the bone defect to be treated as well as the patient’s weight, height, occupation, or degree of physical activity.
  • Proper handling of the implant before and during the operation is crucial.
  • Use of the cover plate to prevent back-out of the screws is mandatory.
  • If a cover plate is disassembled from a plate, it must be discarded and not reused.
  • If a plate is disassembled from a PEEK-OPTIMA interbody implant, it must be discarded and not reused.
  • The Durango device must not be used with vertebral components or instruments from other manufacturers.
  • Before use, inspect all instrumentation for possible damage, wear, or non-function. Damaged or defective instruments should not be used or processed. Contact your local Zimmer Biomet representative or distributor for repair or replacement.
  • The use of an instrument for tasks other than those for which they are indicated may result in damaged or broken instruments.
  • Do not apply excessive force or stress. Misuse can damage instruments or implants.
  • Perform a careful preoperative review to be sure that all necessary implant components are available and that the instrument set is complete and in working order prior to initiating surgery.
  • The Durango system has not been tested for safety and compatibility in the magnetic resonance (MR) environment. The Durango system has not been tested for heating or migration in the MR environment.
  • Mixing of dissimilar metals can accelerate or initiate the corrosion process. Titanium components must NOT be used together in building a construct that involves other implant materials. Titanium and cobalt chrome may be used together within the same construct.

Legal Manufacturer:

Zimmer Biomet Spine, Inc.
10225 Westmoor Dr.
Westminster, CO 80021


All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet.  
This material is intended for health care professionals.  Distribution to any other recipient is prohibited.
For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and information on this website. To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support.