INDICATIONS, SAFETY, AND WARNINGS PIVOX Oblique Lateral Spinal
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.
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.
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.
The PIVOX™ Oblique Lateral Spinal System is not intended for posterior surgical implantation. Contraindications include, but are not limited to:
Nota bene: although not absolute contraindications, conditions to be considered as potential factors for not using this device include:
Warning: this plate device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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:
Note: additional surgery may be necessary to correct some of these potential adverse events.
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.
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Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
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.
The physician's postoperative directions and warnings to the patient and the corresponding patient compliance are extremely important.
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.
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.
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.
To report any product problems, contact Medtronic.
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.
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