ZEVO™ ANTERIOR CERVICAL PLATE
M708348B389E Rev. A
SYSTEM
2014-12-03
IMPORTANT INFORMATION ON THE ZEVO™ ANTERIOR CERVICAL PLATE SYSTEM
PURPOSE
The ZEVO™ Anterior Cervical Plate System implant components are temporary implants intended for anterior interbody screw
fixation of the cervical spine during the development of a cervical spinal fusion. The implantation of the ZEVO™
Plate System is via an anterior surgical approach.
DESCRIPTION
The ZEVO™ Anterior Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting
bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The ZEVO™ Plates include anti-
migration caps that cover the heads of the bone screws to reduce the potential for screw back-out. The anti-migration caps are
shipped pre-assembled to the plate. The implants are supplied both sterile and non-sterile.
The ZEVO™ Anterior Cervical Plate System implant components are made from titanium alloy, with plates having
subcomponents manufactured from Nitinol-NiTi. Stainless steel and titanium implant components must not be used together in a
construct.
Do not use ZEVO™ Anterior Cervical Plate System components with components from any other system or manufacturer. No
warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are
specifically excluded.
Anterior Cervical
INDICATIONS
The ZEVO™ Anterior Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1. 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
The ZEVO™ Anterior Cervical Plate System is not intended for posterior surgical implantation.
Contraindications include, but are not limited to:
▪ Any case needing to mix metals from different components.
▪ Any case not needing a bone graft and fusion or where fracture healing is not required.
▪ Any case not described in the Indications.
▪ Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence
of tumors or congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white
blood count (WBC), or a marked left shift in the WBC differential count.
▪ Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone
quality, or anatomical definition.
▪ Any patient unwilling to cooperate with the post-operative instructions.
▪ Any time implant utilization would interfere with anatomical structures or expected physiological performance.
▪ Fever or leukocytosis.
▪ Infection local to the operative site.
▪ Morbid obesity.
▪ Mental illness.
▪ Pregnancy.
▪ Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. Osteoporosis is a relative contraindication since this
condition may limit the degree of obtainable correction, the amount of mechanical fixation, and/or the quality of the bone
graft.
▪ Signs of local inflammation.
▪ Suspected or documented metal allergy or intolerance.
NOTA BENE: this device system is intended for anterior cervical intervertebral body fusions only. 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 or complications associated with spinal fusion surgery without instrumentation are possible.
With instrumentation, a listing of possible adverse events or complications includes, but is not limited to:
▪ Atelectasis, ileus, gastritis, herniated nucleus pulposus, and/or retropulsed graft.
▪ Bone loss or decrease in bone density, possibly caused by stress shielding.
▪ Bursitis and tissue damage caused by improper positioning and placement of implants or instruments.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Change in mental status.
▪ Death.
▪ Development of respiratory problems (e.g., pulmonary embolism, bronchitis, pneumonia, etc.).
▪ Disassembly, bending, and/or breakage of any or all of the components.
▪ Dural tears.
▪ Dysphagia.
▪ Early or late loosening 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.
▪ 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.
▪ Gastrointestinal and/or reproductive system compromise, including sterility and loss of consortium.
▪ Graft donor site complications including pain, fracture, or wound healing problems.
▪ Hemorrhage, hematoma, seroma, embolism, edema, stroke, excessive bleeding, phlebitis, wound necrosis, wound
dehiscence, or damage to blood vessels.
▪ Inability to perform the activities of daily living.
▪ Interference with roentgenographic, CT, and/or MR imaging because of the presence of the implants.
▪ Infection.
▪ Loss of bowel and/or bladder control or other types of urological system compromise.
▪ 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.
▪ Loss of spinal mobility or function.
▪ Neuropathy, neurological deficits (transient or permanent), bilateral paraplegia, reflex deficits, and/or arachnoiditis.
▪ Non-union (or pseudarthrosis), delayed union, and mal-union.
▪ Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing
skin penetration, irritation, and/or pain.
▪ Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Scar formation possibly causing neurological compromise around nerves and/or pain.
Note: Additional surgery may be necessary to correct some of these anticipated adverse events.
WARNINGS AND PRECAUTIONS
This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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 ZEVO™ Anterior Cervical Plate System is only a temporary
implant used for the correction and stabilization of the spine. This system is also intended 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 ZEVO™ 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 ZEVO™ Anterior Cervical Plate System 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. Implants
which have come in contact with the patient are designed for single patient use only. 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.
PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and the patient, the important
medical information given in this document should be conveyed to the patient.
FOR US AUDIENCES ONLY
CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
IMPLANT SELECTION
The selection of the proper size, shape, and design of the implant for each patient is crucial to the success of the procedure.
Metallic surgical implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to
the size and shape of human bones. Unless great care is taken in patient selection, proper placement of the implant, and
postoperative management to minimize stresses on the implant, such stresses may cause metal fatigue and consequent
breakage, bending or loosening of the device before the healing process is complete, which may result in further injury or the
need to remove the device prematurely.
PREOPERATIVE
▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and/or predispositions such as those addressed in the aforementioned 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 implant 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 all parts and necessary instruments are present before
surgery. The ZEVO™ Anterior Cervical Plate System components are not to be combined with the components from
another manufacturer. Different metal types should not be used together.
▪ Unless sterile packaged, all parts should be cleaned and sterilized before use. Additional sterile components should be
available in case of an unexpected need.
INTRAOPERATIVE
▪ The instructions provided in any available applicable surgical technique manual should be carefully followed.
▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves will cause loss of
neurological functions.
▪ When the configuration of the bone cannot be fitted with an available temporary internal 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 any more than
absolutely necessary. The components should not be reverse bent at the same location.
▪ The implant surfaces should not be scratched or notched, since such actions may reduce the functional strength of the
construct.
▪ Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
▪ Bone grafts must be placed in the area to be fused and the graft must be extended from the upper to the lower vertebrae to
be fused.
▪ Bone cement should not be used since this material will make removal of the components difficult or impossible. The heat
generated from the curing process may also cause neurologic damage and bone necrosis.
▪ Before closing the soft tissues, all bone screws should be seated onto the plate. Recheck the tightness of all screws after
finishing to make sure none have loosened during the tightening of the other screws. Also, secure the locking mechanism
into place to cover the screw heads. Failure to do so may result in screw loosening. Caution: Excessive torque on the
threads may cause the threads to strip in the bone, reducing fixation.
POSTOPERATIVE
The physician’s postoperative directions and warnings to the patient, and the corresponding patient compliance, are extremely
important.
▪ Detailed instructions on the use and limitations of the device should be given to the patient. If partial weight-bearing is
recommended or required prior to firm bony union, the patient must be warned that bending, loosening, or breakage of the
components are complications which can occur as a result of excessive or early weight-bearing or excessive muscular
activity. The risk of bending, loosening, or breakage of a temporary internal fixation device during postoperative
rehabilitation may be increased if the patient is active, or if the patient is debilitated, demented, or otherwise unable to use
crutches or other such weight supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal
position.
▪ To allow the maximum chances for a successful surgical result, the patient or device should not be exposed to mechanical
vibrations that may loosen the device construct. The patient should be warned of this possibility and instructed to limit and
restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient should be
advised not to smoke or consume alcohol during the bone graft healing process.
▪ The patient should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this
permanent physical restriction in body motion.
▪ If a non-union develops or if the components loosen, bend, and/or break, the device(s) should be revised and/or removed
immediately before serious injury occurs. Failure to immobilize a delayed or non-union of bone will result in excessive and
repeated stresses on the implant. By the mechanism of fatigue, these stresses can cause eventual bending, loosening, or
breakage of the device(s). It is important that immobilization of the spinal surgical site be maintained until firm bony union is
established and confirmed by roentgenographic examination. The patient must be adequately warned of these hazards and
closely supervised to ensure cooperation until bony union is confirmed.
▪ The ZEVO
designed to stabilize the operative site during the normal healing process. After the spine is fused, these devices serve no
functional purpose and should be removed. In most patients, removal is indicated because the implants are not intended to
transfer or support forces developed during normal activities. If the device is not removed following completion of its
intended use, one or more of the following complications may occur: (1) corrosion with localized tissue reaction or pain, (2)
migration of implant position possibly resulting in injury, (3) risk of additional injury from post-operative 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.
™
Anterior Cervical Plate System implants are temporary internal fixation devices. Internal fixation devices are
▪ While the surgeon must make the final decision on implant removal, it is the position of the Orthopedic Surgical
Manufacturers Association that whenever possible and practical for the individual patient, bone fixation devices should be
removed once their service as an aid to healing is accomplished, particularly in younger and more active patients. Any
decision to remove the device should take into consideration the risk to the patient of a second surgical procedure and the
difficulty of removal. Implant removal should be followed by adequate postoperative management to avoid fracture.
▪ Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible. None of
the ZEVO™
Anterior Cervical Plate System components should ever be reused under any circumstances.
PACKAGING
Devices may be supplied in a sterile or non-sterile form. Packages for each of the components should be intact upon receipt.
Once the seal on a sterile package has been broken, the product should not be re-sterilized. If a loaner or consignment system
is used, all sets should be carefully checked for completeness and all components should be carefully checked to ensure there
is no damage prior to use. Damaged packages or products should not be used, and should be returned to Medtronic.
STERILIZATION
Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants used in
surgery must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization. Only sterile products
should be placed in the operative field. Unless specified elsewhere, these products are recommended to be steam sterilized by
the hospital using one of the following sets of process parameters:
Table 1: Sterilization Cycle Parameters for the United States and its Territories
METHOD CYCLE TEMPERATURE EXPOSURE TIME
Steam Gravity Displacement 250°F (121°C) 30 Minutes 30 Minutes
Steam Gravity Displacement 270°F (132°C) 15 Minutes 30 Minutes
Steam Gravity Displacement 275°F (135°C) 10 Minutes 30 Minutes
Steam Dynamic-Air-Removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-Air-Removal 275°F (135°C) 3 Minutes 16 Minutes
NOTE: It is the end user’s responsibility to use only sterilizers and accessories (such as sterilization wraps, sterilization
pouches, chemical indicators, biological indicators, and sterilization cassettes) cleared by the Food and Drug Administration
(FDA) for the selected sterilization cycle specifications (time and temperature). The sterilization cycles listed in Table 2 are not
considered by the FDA to be standard sterilization cycles.
For Medical Facilities Located Outside the United States and its Territories. Some non-U.S. health care authorities
recommend sterilization according to these parameters to minimize the potential risk of transmission of Creutzfeldt-Jakob
disease, especially of surgical instruments that could come into contact with the central nervous system.
MINIMUM DRY TIME
1
Table 2: Sterilization Cycle Parameters for Medical Facilities Outside the United States and Its Territories
METHOD CYCLE TEMPERATURE EXPOSURE TIME
Steam Gravity Displacement 273°F (134°C) 20 Minutes 30 Minutes
Steam Dynamic-Air-Removal 273°F (134°C) 4 Minutes 30 Minutes
Steam Dynamic-Air-Removal 273°F (134°C) 20 Minutes 30 Minutes
1
The minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient
atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations.
NOTE: Chamber size and chamber load differences may exist between industrial and health care facility sterilizer models. The
sterilization parameters listed in Tables 1 and 2 can be achieved in both health care facility and larger, industrial sterilizer
models. Because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization
process (e.g., temperatures, times) used for their equipment.
MINIMUM DRY TIME
1
MRI INFORMATION
The ZEVO™ Anterior Cervical Plate System has not been evaluated for safety, heating, migration, or compatibility in the
magnetic resonance environment.
PRODUCT COMPLAINTS
Any health care professional (e.g., customer or user of this system of products) who has any complaints or who has
experienced any dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness, and/or performance,
should notify the distributor or Medtronic. Further, if any of the implanted spinal system component(s) ever “malfunctions” (i.e.,
does not meet any of its performance specifications or otherwise does not perform as intended), or is suspected of doing so, the
distributor should be notified immediately. If any Medtronic product ever malfunctions and may have caused or contributed to
the death or serious injury of a patient, the distributor should be notified immediately by telephone, fax, or written
correspondence. When filing a complaint, provide the component(s) name and number, lot number(s), your name and address,
the nature of the complaint, and notification of whether or not a written report from the distributor is requested.
FURTHER INFORMATION
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is needed or required, contact Medtronic.
©2014 Medtronic Sofamor Danek USA, Inc. All rights reserved.
AUSTRALIAN SPONSOR:
Medtronic Australasia Pty Ltd
97 Waterloo Rd
North Ryde, NSW 2113
Australia
EXPLANATION OF SYMBOLS
Authorized representative in the European Community
CAUTION: Federal law (USA) restricts these devices to sale
by or on the order of a physician.
Do not re-use
Batch code
Manufacturer
Catalogue number
Non-sterile
For US audiences only
The device complies with European Directive MDD 93/42/EEC
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
Telephone: 901 396 3133 (Outside USA)
Fax: 901 396 0356
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
Sterilized using irradiation
Use-by date
Consult instructions for use at this website.
Loading...