ChoiceSpine Ambassador Gebrauchsanweisung

Ambassador™ Anterior Cervical Plate System
Instruction for Use
Implants
General Description:
The Choice Spine Ambassador™ Anterior Cervical Plate System is intended for
anterior screw fixation to the cervical spine. The system consists of a variety of bone
plates and screws. The components are made from titanium alloy such as described
by ASTM F136. Plates and screws are provided non-sterile and must be steam
sterilized by the user prior to use.
Indications for Use:
The Choice Spine Ambassador™ Anterior Cervical Plate System is intended for
anterior cervical fixation (C2-T1) for the following indications: degenerative
disc disease (DDD) (defined as neck pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies),
spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor,
pseudoarthrosis, and failed previous fusion.
Contraindications:
Contraindications include, but are not limited to:
- Active infectious process in the patient, particularly in or adjacent to the spine
or spinal structures Signs of local inflammation
- Morbid obesity
- Pregnancy
- Grossly distorted anatomy due to congenital abnormalities
- Any medical or surgical condition which would preclude the potential
benefit of spinal implant surgery
- Rapid joint disease, bone absorption, osteopenia, osteomalcia, or
osteoporosis. Osteopenia or osteoporosis is a relative contraindication since
this condition may limit the degree of obtainable correction and/or the
amount of mechanical fixation
- Suspected or documented metal allergy or intolerance
- Any patient in which implant utilization would interfere with anatomical
structures or expected physiological performance
- Use of these implants is relatively contraindicated in patients whose activity,
mental capacity, mental illness, alcohol or drug abuse, occupation or life-style
may interfere with their ability to follow post- operative instructions
- Any time implant utilization would interfere with anatomical structures or
expected physiological performance
- Any case not needing a bone graft and fusion or where fracture healing is not
required
Warnings and Precautions:
The Choice Spine Ambassador™ Anterior Cervical Plate System should only be
implanted by surgeons who are fully experienced in the use of such implants
and the required specialized spinal surgery techniques. Further, the proper
selection and compliance of the patient will greatly affect the results. The
surgeon should consider the patient conditions (e.g., smoker, malnutrition,
obesity, alcohol and drug abuse, poor muscle and bone quality), which may
impact system performance. The Choice Spine Ambassador Cervical Plate
System is only a temporary implant used for the correction and stabilization
of the cervical spine. The system is also used to augment the development of
a spinal fusion by providing temporary stabilization. This system is not
intended to be the sole means of spinal support. Autogenous bone grafting
must be part of the spinal fusion procedure in which The Choice Spine
Choice Spine
400 Erin Drive
Knoxville, TN 37919
0086
Ambassador™ Anterior Cervical Plate System is used. Use of this product
without an autogenous bone graft may not be successful. The spinal implant
cannot stand body loads without the support of bone. In this event, bending,
loosening, disassembly and/or breakage of the device will eventually occur. Based
on fatigue testing results, when using the Ambassador Cervical Plate, the
physician/surgeon should consider the levels of implantation, patient weight,
patient activity level, other patient conditions, etc., which may impact on the
performance of this system.
The Choice Spine Ambassador™ Anterior Cervical Plate System has not been
evaluated for safety and compatibility in the MR environment. The Choice Spine
Ambassador Cervical Plate System has not been tested for heating or migration in
the MR environment.
Preoperative:
A successful result is not achieved in every surgical case, especially in spinal
surgery where many extenuating circumstances may compromise results.
Preoperative planning and operating procedures, including knowledge of
surgical techniques, proper reduction, and proper selection and placement of
the implant are critical considerations in achieving a successful result. Only
patients that meet the criteria described in the indications should be selected.
Patient conditions and/or predispositions such as those mentioned in the
contraindications should be avoided.
Care should be used in the handling and storage of the implant components.
The implants should not be scratched or otherwise damaged. Implants and
instruments should be protected during storage, especially from corrosive
environments. The type of construct to be assembled for the case should be
determined prior to beginning the surgery. An adequate inventory of sizes should
be available at the time of surgery, including sizes larger and smaller than those
expected to be used.
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. All components and instruments must be
cleaned and sterilized prior to use. Additional sterile components should be
available in case of unexpected need. Prior to surgery, the patient must be
informed of all potential risks and adverse effects contained in the present
instructions for use.
Intraoperative:
The vertebral levels to be fixated should be well visualized with a linear
anterior surface so that the plate will mount flush with the anterior cervical
spine. The Choice Spine® Ambassador™ Anterior Cervical Plate comes with a
standard lordotic curve. When the configuration of bone cannot be fitted
with an available temporary fixation device, and contouring is absolutely
necessary, it is recommended that such contouring be gradual and great care be
used to avoid notching or scratching the surface of the device(s). The components
should not be repeatedly or excessively bent more than absolutely necessary. The
components should not be reverse bent at the same location. Bending near the
screw holes should be avoided.
The surgeon should follow established practices and specific instructions for
implant of the system. Whenever possible or necessary, an imaging system should
be utilized to verify proper component placement.
Extreme caution should be used around the spinal cord and nerve roots. Damage
to the nerves will cause loss of neurological functions.
Always orient the Ambassador Cervical Plate as close as possible to the spinal
midline.
The appropriately sized plate should be selected with the plate holes directly
anterior to the vertebrae to be fused.
Before closing the soft tissues, ensure that the locking cam has been rotated
to the lock position. Autogenous bone grafts must be placed in the area to
be fused. Bone cement should not be used since
this material will make removal of the components difficult or impossible. The
heat from the curing process may cause neurological damage and bone
necrosis.
Some degree of corrosion occurs on all implanted metal and alloys.
Mixing of dissimilar metals can accelerate the corrosion process.
CS.Ambassador.IFU Rev D 12/17
700-096-150