ATLANTIS® ANTERIOR CERVICAL
M708348B435E Rev. A
PLATE SYSTEM
2014-08-22
IMPORTANT INFORMATION ON THE ATLANTIS® ANTERIOR CERVICAL PLATE
SYSTEM
PURPOSE
The ATLANTIS® Anterior Cervical Plate System components are temporary implants that are intended for anterior interbody
screw fixation of the cervical spine during the development of a cervical spinal fusion.
DESCRIPTION
The ATLANTIS® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and
washers are pre-assembled to the plates), screws, and associated instruments. Fixation is provided by bone screws inserted
into the vertebral body of the cervical spine using an anterior approach.
The ATLANTIS® Anterior Cervical Plate System implant components are made from titanium alloy, with certain plates having
subcomponents manufactured from shape memory alloys (Nitinol-NiTi). Stainless steel and titanium implant components must
not be used together in a construct. Implied warranties of merchantability and fitness for a particular purpose or use are
specifically excluded. Do not use any of the ATLANTIS® Anterior Cervical Plate System components with the components from
any other system or manufacturer.
INDICATIONS
Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. The indications and contraindications
of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary
stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease
(as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic
studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis,
and/or 6) failed previous fusions.
NOTA BENE: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical,
thoracic, or lumbar spine.
CONTRAINDICATIONS
Contraindications include, but are not limited to:
▪ Infection local to the operative site.
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation
of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the
WBC differential count.
▪ Suspected or documented metal allergy or intolerance.
▪ Any case not needing a bone graft and fusion or where fracture healing is not required.
▪ Any case requiring the mixing of metals from different components.
▪ Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone
quality, or anatomical definition.
▪ Any case not described in the Indications.
▪ Any patient unwilling to cooperate with the post-operative instructions.
▪ Any time implant utilization would interfere with anatomical structures or expected physiological performance.
NOTA BENE: Although not absolute contraindications, conditions to be considered as potential factors for not using
this device include:
▪ Severe bone resorption
▪ Osteomalacia
▪ Severe osteoporosis
POTENTIAL ADVERSE EVENTS
All of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With
instrumentation, a listing of potential adverse events includes, but is not limited to:
▪ Early or late loosening of any or all of the components.
▪ Disassembly, bending, and/or breakage of any or all of the components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products, graft material, including metallosis, staining, tumor
formation, and/or auto-immune disease.
▪ Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing
skin penetration, irritation, and/or pain.
▪ Bursitis and tissue damage caused by improper positioning and placement of implants or instruments.
▪ Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Infection.
▪ Dural tears.
▪ Loss of neurological function, including paralysis (complete or incomplete), dysesthesias, hyperesthesia, anesthesia,
paraesthesia, appearance of radiculopathy, and/or the development or continuation of pain, numbness, neuroma, or tingling
sensation.
▪ Neuropathy, neurological deficits (transient or permanent), bilateral paraplegia, reflex deficits, and/or arachnoiditis.
▪ Loss of bowel and/or bladder control or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise around nerves and/or pain.
▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone and/or bone graft or bone graft harvest site
at, above, and/or below the level of surgery.
▪ Interference with roentgenographic, CT, and/or MR imaging because of the presence of the implants.
▪ Non-union (or pseudarthrosis), delayed union, and mal-union.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Loss of spinal mobility or function.
▪ Inability to perform the activities of daily living.
▪ Bone loss or decrease in bone density, possibly caused by stress shielding.
▪ Graft donor site complications including pain, fracture, or wound healing problems.
▪ Atelectasis, ileus, gastritis, herniated nucleus pulposus, and/or retropulsed graft.
▪ Hemorrhage, hematoma, seroma, embolism, edema, stroke, excessive bleeding, phlebitis, wound necrosis, wound
dehiscence, or damage to blood vessels.
▪ Gastrointestinal and/or reproductive system compromise, including sterility and loss of consortium.
▪ Development of respiratory problems (e.g., pulmonary embolism, bronchitis, pneumonia, etc.).
▪ Change in mental status.
▪ Death.
Note: Additional surgery may be necessary to correct some of these anticipated adverse events.
WARNINGS AND PRECAUTIONS
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many
extenuating circumstances may compromise the results. The ATLANTIS® Anterior Cervical Plate System is only a temporary
implant used for the correction and stabilization of the spine. This system is also intended to be used to augment the
development of a spinal fusion by providing temporary stabilization. This device system is not intended to be the sole means of
spinal support. Bone grafting must be part of the spinal fusion procedure in which the ATLANTIS® Anterior Cervical Plate
System is utilized. Use of this product without a bone graft or in cases that develop into a non-union will not be successful. This
spinal implant cannot withstand body loads without the support of bone. In this event, bending, loosening, disassembly and/or
breakage of the device(s) will eventually occur. Preoperative planning and operating procedures including knowledge of surgical
techniques, proper reduction, and proper selection and placement of the implant are important considerations in the successful
utilization of the ATLANTIS® Anterior Cervical Plate by the surgeon. Further, the proper selection and compliance of the patient
will greatly affect the results. Patients who smoke have been shown to have an increased incidence of non-unions. These
patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol and/or other drug
abuse patients are also not good candidates for spine fusion. Patients with poor muscle and bone quality and/or nerve paralysis
are also not good candidates for spine fusion. The implants are not prostheses.
A device that has been implanted should never be reused, reprocessed or resterilized under any circumstances. Sterile
packaged devices should also never be resterilized. Reuse, reprocessing, or resterilization may compromise the structural
integrity of these implants and create a risk of contamination of the implants which could result in patient injury, illness, or death.
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