Sovereign™ Spinal System 0381396E Rev. F
2021-10-13
IMPORTANT INFORMATION ON THE SOVEREIGN™ SPINAL SYSTEM
PURPOSE
The Sovereign™ Spinal System is a fusion system intended for stabilization and to promote bone fusion during the normal
healing process following surgical correction of disorders of the spine. The product should be implanted only by a physician
thoroughly knowledgeable in the implant's material and surgical aspects and instructed as to its mechanical and material
applications and limitations. This system may be implanted via a variety of open or minimally invasive approaches. These
approaches include anterior and oblique.
DESCRIPTION
The Sovereign™ Spinal System is an intervertebral body fusion device with internal screw fixation. Screws protrude through the
interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is lensshaped with 3 holes for placement of titanium screws using an anterior or oblique approach. The Sovereign™ Spinal System
contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the
polyetheretherketone (PEEK) interbody implant. The variable angle screw option provides a slight clearance between the PEEK
interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be
radiolucent and the interior space of the product is to be used with autogenous bone and/or allograft bone graft comprised of
cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The
accompanying cover plate is designed to resist screw backout and must be used when variable angle screws are implanted.
The Sovereign™ Spinal System interbody device is manufactured from PEEK and contains tantalum radiopaque markers.
Screws used with this device are manufactured from titanium alloy.
INDICATIONS
The Sovereign™ Spinal System is indicated for use with autogenous bone and/or allograft bone graft comprised of cancellous
and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate in patients with
degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic studies. Additionally, the Sovereign™ Spinal System is indicated
for use in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions as an adjunct to fusion.
These patients should be skeletally mature and have had 6 months of non-operative treatment. When used in patients as an
adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional
supplemental fixation (e.g. posterior fixation) must be used. These implants may be implanted via a variety of open or minimally
invasive approaches. These approaches include anterior and oblique.
The Sovereign™ Spinal System may be used as a stand-alone device or in conjunction with supplemental fixation.
When used as a stand-alone device, the Sovereign™ Spinal System is intended to be used with 3 titanium alloy fixed or
variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable
angle screws. If the physician chooses to use less than 3 or none of the provided screws, additional supplemental fixation in the
lumbar spine must be used to augment stability. Implants with lordosis angles >18° are intended to be used with supplemental
fixation (e.g. facet screws or posterior fixation).
CONTRAINDICATIONS
This device is not intended for cervical spine use. Contraindications include:
▪ Translational instability (spondylolisthesis of any grade or retrolisthesis) at the levels treated unless posterior supplemental
fixation is used to augment stability.
▪ Cases where posterior elements were removed such that it introduces instability at the level(s) treated unless posterior
supplemental fixation is used to augment stability.
▪ Severe osteoporosis.
▪ Patients having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Infection local to the operative site.
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Condition which would preclude the benefit of spinal implant surgery, such as the presence of tumors or congenital
abnormalities, fracture local to the operating site, 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 allergy or intolerance to composite materials.
▪ Cases not needing a fusion.
▪ Cases not described in the indications.
▪ Patients unwilling to cooperate with postoperative instructions.
▪ Patients with a known hereditary or acquired bone friability or calcification problem should not be considered for this type of
surgery.
▪ These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
▪ Cases where implants would be too large or too small to achieve a successful result.
▪ Cases that require the mixing of metals from 2 different components or systems.
▪ Patients in which implant use would interfere with anatomical structures or expected physiological performance.
▪ Prior fusion at the level to be treated.
Nota bene: although not absolute contraindications, conditions to be considered as potential factors for not using this device
include:
▪ Osteoporosis unless posterior supplemental fixation is used to augment stability.
▪ Severe bone resorption.
▪ Osteomalacia.
POTENTIAL ADVERSE EVENTS
Adverse effects may occur when the device is used either with or without associated instrumentation. Risk of adverse effects as
a result of movement and non-stabilization may increase in cases where associated complementary support is not employed.
Potential adverse events include:
▪ Implant migration.
▪ Breakage of the device.
▪ Foreign body reaction to implants including possible tumor formation, auto immune disease, and/or scarring.
▪ Pressure on the surrounding tissues or organs.
▪ Loss of proper spinal curvature, correction, height, and/or reduction.
▪ Infection.
▪ Bone fracture or stress shielding at, above, or below the level of surgery.
▪ Non-union (or pseudoarthrosis).
▪ Loss of neurological function, appearance of radiculopathy, dural tears, and/or development of pain.
▪ Neurovascular compromise including paralysis, temporary or permanent retrograde ejaculation in males, or other types of
serious injury.
▪ Cerebral spinal fluid leakage.
▪ Hemorrhage of blood vessels and/or hematomas.
▪ Discitis, arachnoiditis, and/or other types of inflammation.
▪ Deep venous thrombosis, thrombophlebitis, and/or pulmonary embolus.
▪ Autogenous bone graft donor site complication.
▪ Inability to resume activities of normal daily living.
▪ Early or late loosening or movement of the device.
▪ Urinary retention, loss of bladder control, or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise or compression around nerves and/or pain.
▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and/or
vertebral body) and/or autogenous bone graft or bone graft harvest site at, above, and/or below the level of surgery.
▪ Retropulsed graft.
▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
▪ Loss of or increase in spinal mobility or function.
▪ Reproductive system compromise including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
▪ Change in mental status.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Death.
WARNINGS
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 results. Supplemental fixation systems which may be used with this device include CD
Horizon™ Spinal System, TSRH™ Spinal System, Dynalok™ Classic Spinal System, Z-Plate II™ Anterior Fixation System,
Pyramid™ Anterior Plate Fixation System, and/or their successors. When additional support instrumentation is used, refer to the
package insert for requirements and limitations related to those devices.
Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without
a previous spinal surgery.
Use of this product without autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone
graft, and/or demineralized allograft bone with bone marrow aspirate 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 will
eventually occur.
Preoperative and operating procedures, including knowledge of surgical techniques, proper selection and placement of
implants, and good reduction are important considerations in the success of surgery.
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 stability of
instrumentation. Retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.
A device that has been implanted should never be reprocessed or reused under any circumstances. Sterile packaged devices
should also never be resterilized. Reprocessing or reuse 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.
Further, proper selection and compliance of patients greatly affect results. Patients who smoke were 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 abuse patients are also poor candidates for spine fusion.
PRECAUTIONS
Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information 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
Selection of proper size, shape, and design of implants for each patient is crucial to success of the procedure. Plastic polymer
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 implants, 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
▪ Care should be used when handling and storing implants. Implants should not be scratched or 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
surgery.
▪ The type of construct to be assembled for the case 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.
▪ Unless sterile packaged, implants should be sterilized before use. Additional sterile implants should be available in case of
an unexpected need.
INTRAOPERATIVE
▪ Instructions in any available Sovereign™ Spinal System 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.
▪ Breakage, slippage, or misuse of instruments or implants may cause injury to the patient or operative personnel.
▪ To ensure proper fusion below and around the location of the fusion, autogenous bone and/or allograft bone graft
comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow
aspirate must be used.
▪ Bone cement should not be used because this material may make removal of these components difficult or impossible.
Heat generated from the curing process may damage or deform PEEK devices.
POSTOPERATIVE
The physician's postoperative directions and warnings to patients and corresponding patient compliance are extremely
important.
▪ Detailed instructions on use and limitations of the device should be given to patients. If partial weight bearing is
recommended or required prior to firm bony union, patients must be warned that bending, loosening, or breakage of the
device are complications which can occur as a result of excessive weight bearing or muscular activity. Risk of bending,
loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be increased if the
patient is active, debilitated, demented, or unable to use weight supporting devices. Patients should be warned to avoid falls
or sudden jolts in spinal position.
▪ To allow maximum chances for a successful surgical result, patients or devices should not be exposed to mechanical
vibrations that may loosen the device construct. Patients 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. Patients should be
advised not to smoke or consume excess alcohol during the autogenous bone and/or allograft bone graft comprised of
cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate 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 implants. By the
mechanism of fatigue, these stresses can cause eventual bending, loosening, or breakage of the device. It is important that
immobilization of the union is established and confirmed by roentgenographic examination. Where there is a non-union, or if
components loosen, bend, and/or break, the device should be revised and/or removed immediately before serious injury
occurs.
MRI INFORMATION
MR Conditional
In non-clinical testing the Sovereign™ Spinal System was determined to be MR Conditional. A patient with this device can be
scanned safely, immediately after placement under the following conditions:
Static Magnetic Field
▪ Static magnetic field of 1.5 and 3 Tesla.
▪ Maximum spatial gradient magnetic field of 3000 Gauss/cm or less.
▪ Maximum whole body average specific absorption rate (SAR) of 2.0 W/kg or less under normal operating mode for 15
minutes of scanning per pulse sequence.
MRI-Related Heating
In non-clinical testing, the Sovereign™ Spinal System produced the following temperature rise during an MRI (Magnetic
Resonance Imaging) performed for 15 minutes of scanning (i.e. per pulse sequence) in 1.5 Tesla/64 MHz MR system
(Magnetom, Siemens Medical Solutions, Malvern, PA. Software Numaris/4, Version Syngo MR 2002B DHHS Active –shielded,
horizontal field scanner) and 3 Tesla/128 MHz, (Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI)
MR system:
1.5 Tesla 3 Tesla
MR system reported, whole body average SAR 2.9 W/kg 2.9 W/kg
Calorimetry Measured values, whole body averaged SAR 2.1 W/kg 2.7 W/kg
Highest temperature change 1.8°C 1.7°C
Artifact Information
MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the
Sovereign™ Spinal System. The artifact size information follows:
Pulse sequence T1-SE T1-SE GRE GRE
Signal void size
Imaging plane parallel perpendicular parallel perpendicular
Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary. The
maximum artifact size (i.e. as seen on the gradient echo pulse sequence) extends approximately 20mm relative to the size and
shape of the Sovereign™ Spinal System.
1540mm
2
1397mm
2
3595mm
2
3782mm
2
MRI Patient Counseling Information
Physicians should communicate with the patient the following information about MRI with respect to the Sovereign™ Spinal
System:
▪ Sovereign™ Spinal System performance was established for MRI systems at field strengths of 1.5 and 3.0 Tesla.
▪ During an MRI, the patient may notice a warming sensation around the implant or feel a tingling sensation. If the warming or
tingling sensation is uncomfortable, the patient should communicate this to the MR technologist, the MRI should be
stopped, and the settings adjusted to reduce or eliminate the sensation. The highest temperature change observed in nonclinical testing was +1.8ºC (associated with specific conditions previously listed).
▪ Additionally, the metal in the implant may cause the MRI image to be distorted in the area around the implant. The MRI can
be adjusted to minimize image distortion.
Physicians should instruct patients to:
▪ Inform healthcare personnel (e.g. doctor or MR technologist) an implanted interbody device exists prior to receiving an MRI.
▪ The patient’s doctor will recommend whether or not an MRI is appropriate.
If the Sovereign™ Spinal System is used in connection with any device which is not MR Conditional, be advised this
combination has not been tested in the MR environment and, therefore, higher heating and possible injury to the patient may
occur.
PACKAGING
Devices may be supplied sterile or non-sterile. Packages for each of the devices should be intact upon receipt. Once the seal on
the sterile package is broken, the product should not be re-sterilized. 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 Medtronic, 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 sets of process parameters in Table 1.
Table 1: Sterilization cycle parameters for the US and its territories
Method Cycle Temperature Exposure time
Minimum dry time
Steam Dynamic-air-removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 275°F (135°C) 3 Minutes 16 Minutes
1
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 in Table 1 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.
1
PRODUCT COMPLAINTS
To report 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 required, contact Medtronic.
©2021 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
Do not use if package is damaged and consult instructions
for use
Batch code
Manufacturer
Date of manufacture
Catalogue number
Non-sterile
Sterilized using irradiation
Use-by date
For US audiences only
MR Conditional
Consult instructions for use at this website.
*Single sterile barrier system
Double sterile barrier system
Single sterile barrier system with protective packaging
inside
Single sterile barrier system with protective packaging
outside
*Single barrier packaging systems may not contain a
sterile barrier system symbol. Per ISO 11607-1, a symbol
is only required if more than one barrier is present.
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