Pivox™ Oblique Lateral Spinal
M708348B494E Rev. C
System
2019-03-07
IMPORTANT INFORMATION ON THE PIVOX™ OBLIQUE LATERAL SPINAL SYSTEM
PURPOSE
The Pivox™ Oblique Lateral Spinal System consists of fusion devices (interbody cages) intended to stabilize and promote bone
fusion during the normal healing process following surgical correction of disorders of the spine and temporary implants (plates
and bone screws) intended for anterior column screw fixation. The product should be implanted only by a physician thoroughly
knowledgeable in the implant's material and surgical aspects and who has been instructed as to its mechanical and material
applications and limitations.
The Pivox™ Oblique Lateral Spinal System is intended for in vivo use, to provide stabilization and to promote bone fusion
between two adjacent lumbar vertebral bodies, and is to be used with autogenous bone graft and/or allograft material, or
Infuse™ Bone Graft (as designated below with the Pivox™ Oblique Lateral Spinal System Interbody Cage) to facilitate fusion.
DESCRIPTION
The Pivox™ Oblique Lateral Spinal System consists of interbody cages, plates, and bone screws.
The Pivox™ Oblique Lateral Spinal System interbody cages are available in various widths, heights, and lordosis inserted
between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow
geometry of the implants allows them to be packed with autogenous bone graft and/or allograft, or Infuse™ Bone Graft (as
designated below) and must be used with supplemental fixation. The cages are manufactured from medical grade
polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.
The Pivox™ Oblique Lateral Spinal System plates and bone screws are available in a broad range of sizes intended for anterior
column screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine.
Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior, lateral, or oblique
approach. The Pivox™ Oblique Lateral Spinal System plate and bone screws are made from titanium alloy and are provided
sterile.
Medical grade titanium and medical grade PEEK may be used together. Never use titanium or titanium alloy implants with
stainless steel in the same construct.
No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use
are specifically excluded.
INDICATIONS
The Pivox™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autograft and/or allogenic bone graft
comprised of cancellous and/or corticocancellous bone graft to facilitate interbody fusion and is intended for use with
supplemental fixation systems cleared for use in the lumbar spine. The Pivox™ Oblique Lateral Spinal System interbody cage is
used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients
may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain
with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Pivox™ Oblique Lateral Spinal
System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to
pedicle screw fixation. These patients should be skeletally mature and have had six months of non- operative treatment. These
implants may be implanted via a minimally invasive or open lateral or oblique approach.
Certain sizes of the Pivox™ Oblique Lateral Spinal System Interbody Cage may also be used with Infuse™ Bone Graft for
patients diagnosed with DDD, as defined above, who are skeletally mature and have had six months of non-operative treatment.
The device may be implanted at a single level using an Oblique Lateral Interbody Fusion (OLIF) approach from L2- L5 and is
intended for use with supplemental fixation systems cleared for use in the lumbar spine. Consult the labeling for the Infuse™
Bone Graft/Medtronic Interbody Fusion Device for information on the specific sizes of the Pivox™ Oblique Lateral Spinal
System Interbody Cage approved for use with Infuse™ Bone Graft, as well as specific information regarding contraindications,
warnings, and precautions associated with Infuse™ Bone Graft. Infuse™ Bone Graft is not indicated for use in a direct lateral
interbody fusion (DLIF) surgical approach.
Additionally, the Pivox™ Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed
with degenerative scoliosis as an adjunct to pedicle screw fixation.These patients should be skeletally mature and have had six
months of non- operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique
approach. Infuse™ Bone Graft is not indicated for use in patients with this condition.
The Pivox™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device
for the lumbosacral levels, anterior below the bifurcation (L5-S1) of the vascular structures, and oblique or lateral above the
bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be
understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the
anterior lumbar spine during the development of spinal fusions in patients with: 1) DDD defined by back 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.
When used together, the Pivox™ Oblique Lateral Spinal System components can be used to treat patients with DDD at one or
two contiguous levels from L2 to S1 (except as defined for use with Infuse™ Bone Graft above). These DDD patients may also
have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.
CONTRAINDICATIONS
The Pivox™ Oblique Lateral Spinal 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 described in the indications.
▪ Any medical or surgical condition which would preclude the 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 postoperative instructions.
▪ Any case not needing a bone graft and fusion or where fracture healing is not required.
▪ Any time implant utilization would interfere with anatomical structures or expected physiological performance.
▪ Fever or leukocytosis.
▪ For interbody cage, patients with known hereditary or acquired bone friability or calcification problems.
▪ For interbody cage, prior fusion at the level to be treated.
▪ Infection local to the operative site and/or signs of local inflammation.
▪ Mental illness.
▪ Morbid obesity.
▪ Pregnancy.
▪ Spondylolisthesis unable to be reduced to Grade 1.
▪ Suspected or documented allergy or intolerance to the component materials.
▪ These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
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.
Warning: this plate device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or
lumbar spine.
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:
▪ Bone loss or decrease in bone density, possibly caused by stress shielding.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Change in mental status.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
▪ Disassembly, bending, and/or breakage of any or all of the components.
▪ Disc disruption or degeneration at, above, or below the level of surgery.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis.
▪ Damage to the anterior vasculature.
▪ Damage to the peritoneum.
▪ Early or late loosening of the components and implant migration.
▪ For interbody cage, cauda equina syndrome.
▪ For plate device, atelectasis, ileus, gastritis.
▪ For plate device, dysphagia.
▪ For plate device, pressure on the skin from component parts in patients with inadequate tissue coverage over the implant
possibly causing skin penetration, irritation, and/or pain.
▪ For plate device, bursitis.
▪ Foreign body (allergic) reaction to the implants, debris, corrosion products including metallosis, staining, tumor formation,
and/or autoimmune disease.
▪ Fracture, microfracture, resorption, damage, penetration, and/or retropulsion of any spinal bone, or autograft, or at the bone
graft harvest site at, above, and/or below the level of surgery.
▪ Gastrointestinal complications.
▪ Graft donor site complications including pain, fracture, infection, or wound healing problems.
▪ Hemorrhage, hematoma, occlusion, seroma, edema, embolism, stroke, excessive bleeding, phlebitis, wound necrosis,
wound dehiscence, damage to blood vessels, or cardiovascular system compromise.
▪ Herniated nucleus pulposus and/or retropulsed graft.
▪ Gastrointestinal and/or reproductive system compromise including sterility and loss of consortium.
▪ Infection.
▪ Loss of bowel and/or bladder control or other types of urological system compromise.
▪ Loss of neurological function, including paralysis (complete or incomplete), dysesthesia, hyperesthesia, anesthesia,
paraesthesia, appearance of radiculopathy, and/or the development or continuation of pain, numbness, neuroma, tingling
sensation, sensory loss, and/or spasms.
▪ Loss of spinal mobility or function and inability to perform the activities of daily living.
▪ Interference with roentgenographic, CT, and/or MR imaging because of the presence of the implants.
▪ Neuropathy, neurological deficits (transient or permanent), bilateral paraplegia, reflex deficits, arachnoiditis, and/or muscle
loss.
▪ Non-union (or pseudarthrosis), delayed union, and mal-union.
▪ Postoperative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Scar formation possibly causing neurological compromise around nerves and/or pain.
▪ Subsidence of the interbody cage device into vertebral body(ies).
▪ Tissue or nerve damage, irritation, and/or pain caused by improper positioning and placement of implants or instruments.
▪ Wound necrosis or wound dehiscence.
▪ Death.
Note: additional surgery may be necessary to correct some of these potential 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 other
patient conditions may compromise the results.
The Pivox™ Oblique Lateral Spinal System plate and bone screw components are temporary implants used for the correction
and stabilization of the spine. This system is also intended to augment the development of spinal fusion by providing temporary
stabilization. This plate and bone screw system is not intended to be the sole means of spinal support. An interbody cage must
be part of the spinal fusion procedure in which the Pivox™ Oblique Lateral Spinal System plate and bone screws are utilized.
Use of the plate and bone screw device without interbody fusion may not be successful.
Use of the Pivox™ Oblique Lateral Spinal System Interbody Cage component in lumbar interbody fusion procedures without
autogenous bone graft and/or allograft, or Infuse™ Bone Graft (as designated above), may not be successful.
No spinal implant can 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 and operating procedures including knowledge of surgical techniques, proper selection and placement of the
implant, and good reduction are important considerations in the success of surgery. Patients with previous spinal surgery at the
levels to be treated may have different clinical outcomes compared to those without a previous spinal surgery. This system
should not be used in any case not described in the indications.
Never reuse an internal fixation device under any circumstances. Even when a removed device appears undamaged, it may
have small defects or internal stress patterns that may lead to early breakage. Damage of the thread will reduce the stability of
the instrumentation. Further, the proper selection and compliance of the patient will greatly affect the results. Patients who
smoke 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 abuse patients are also poor candidates for spine fusion. Patients with poor
muscle and bone quality and/or nerve paralysis are also not good candidates for spine fusion.
A device that has been implanted should never be reused, reprocessed, or resterilized under any circumstances. Sterile
packaged devices are never to be resterilized. Reuse, reprocessing, or re-sterilization 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.
Based on fatigue testing results, when using the Pivox™ Oblique Lateral Spinal System cage, the physician/surgeon should
consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact the
performance of this system.
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.
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 material 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.
▪ 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 the
surgery begins. Different metal types should not be used together.
▪ The type of construct assembled should be determined prior to 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.
▪ These devices are provided sterile. Additional sterile components should be available in case of an unexpected need.
INTRAOPERATIVE
▪ The instructions in any applicable surgical technique manual should be carefully followed.
▪ The Pivox™ Oblique Lateral Spinal System plate is not designed to be contoured.
▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss
of neurological functions.
▪ 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.
▪ To ensure proper fusion below and around the location of the instrumentation, autogenous bone graft and/or allograft must
be used in all lumbar interbody fusion procedures. The graft material is to be placed in the area to be fused and the graft
material must extend from the upper to the lower vertebrae being 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 to
ensure none have loosened during the tightening of the other screws. Lock the anti-migration cap over the heads of the
screws. Failure to do so may result in screw loosening. Caution: excessive torque on the threads may cause the threads to
strip in the bone and may reduce 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
device components are complications which can occur as a result of excessive weight bearing or 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
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 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 healing process.
▪ Patients 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.
▪ 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. 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. The patient must be adequately warned of
these hazards and closely supervised to ensure cooperation until bony union is confirmed.
▪ The Pivox™ Oblique Lateral Spinal System plate and bone screw components are temporary internal fixation devices.
Internal fixation devices are 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 postoperative 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.
▪ 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.
MAGNETIC RESONANCE SAFETY
The Pivox™ Oblique Lateral Spinal System has not been evaluated for safety and compatibility in the MR environment. It has
not been tested for heating, migration, or image artifact in the MR environment. The safety of Pivox™ Oblique Lateral Spinal
System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
PACKAGING
Implants are supplied in a sterile form. Packages for each of the implants should be intact upon receipt. Once the seal on the
sterile package has been broken, the product should not be re-sterilized. Damaged packages or products should not be used,
and should be returned to Medtronic.
STERILIZATION
Devices are supplied in a sterile form. Never autoclave or in any other way attempt to re-sterilize or re-use the Pivox™ Oblique
Lateral Spinal System implants.
PRODUCT COMPLAINTS
To report any product problems, contact Medtronic.
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.
©2019 Medtronic Sofamor Danek USA, Inc. All rights reserved.
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
EXPLANATION OF SYMBOLS
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
For US audiences only
Sterilized using irradiation
Use-by date
Consult instructions for use at this website.
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