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.