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 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
- 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.
- 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
- Any case requiring the mixing of components from two
- Any case requiring the mixture of
stainless steel with titanium, or stainless steel with cobalt chrome
- Fever or leukocytosis.
of local infection or inflammation.
- Previous history of
- 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.
patient unwilling to follow postoperative instructions.
- Inadequate tissue coverage over the operative site.
Possible complications specific to the device may include:
- Early or late implant bending, breakage, failure, loosening or
- 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.
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.
- 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
- 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.
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
- 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.
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
- 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
- If a plate is disassembled from a PEEK-OPTIMA
interbody implant, it must be discarded and not reused.
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
- 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
- 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.