Medtronic 6284044 Instructions for Use

Cornerstone™ PSR Cervical Fusion

M708348B057E Rev. D

System
Cervical Interbody Fusion Device

2020-04-03

IMPORTANT INFORMATION ON THE CORNERSTONE™ PSR INTERBODY FUSION
DEVICE

PURPOSE

This device is a fusion device intended for stabilization use 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 device is manufactured from medical grade polyetheretherketone (PEEK) with tantalum or titanium alloy wire
markers and is provided sterile.

DESCRIPTION

The Cornerstone™ PSR Cervical Interbody Fusion Device consists of cages of various widths and heights, which can be
inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The
hollow geometry of the implants allows them to be packed 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 cervical fusion

procedures. The Cornerstone
be implanted via an open, anterior approach.

No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use
are specifically excluded.

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.

™

PSR Cervical Interbody Fusion Device is to be used with supplemental instrumentation and is to

INDICATIONS

The Cornerstone™ PSR Cervical Interbody Fusion Device is indicated for cervical interbody fusion procedures in skeletally
mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined
as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates
producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used

in patients who have had six weeks of non-operative treatment. The Cornerstone
be used with supplemental fixation. The Cornerstone

autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized
allograft bone with bone marrow aspirate and is to be implanted via an open, anterior approach.

™

PSR Cervical Interbody Fusion Device is also required to be used with

™

PSR Cervical Interbody Fusion Device is to

CONTRAINDICATIONS

The Cornerstone™ PSR Cervical Interbody Fusion Device is not intended for posterior surgical implantation. Contraindications
include:

▪ 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 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 postoperative instructions.
▪ Fever or leukocytosis.
▪ Infection local to the operative site and/or signs of local inflammation.
▪ Mental illness.

▪ Morbid obesity.
▪ Pregnancy.
▪ Any case not requiring fusion.
▪ Suspected or documented allergy or intolerance to component materials.
▪ This device must not be used for pediatric cases, nor where the patient still has general skeletal growth.
▪ Patients with a known hereditary or required bone friability or calcification problem should not be considered for this type of

surgery.

▪ Prior fusion at the level to be treated.
▪ Any patient in which implant use would interfere with anatomical structures or expected physiological performance.
▪ Spondylolisthesis unable to be reduced to Grade 1.
▪ Any case that requires the mixing of metals from different components or systems.

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.

POTENTIAL ADVERSE EVENTS

All adverse events or complications associated with spinal fusion surgery without instrumentation are possible. With
instrumentation, a listing of possible adverse events or complications includes:

▪ Bone loss or decrease in bone density possibly caused by stress shielding.
▪ Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits,

arachnoiditis, and/or muscle loss.

▪ Loss of spinal mobility or function and inability to perform the activities of daily living.
▪ Change in mental status.
▪ Death.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
▪ Disassembly, bending, and/or breakage of components.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis.
▪ Early or late loosening of components.
▪ Implant migration.
▪ 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, of the autograft, or at the

bone graft harvest site at, above, and/or below the level of surgery.

▪ Ileus, gastritis, bowel obstruction, or other types of gastrointestinal complications.
▪ Graft donor site complications including pain, fracture, infection, or wound healing problems.
▪ Hemorrhage, hematoma, occlusion, seroma, edema, embolism, stroke, excessive bleeding, phlebitis, damage to blood

vessels, or cardiovascular system compromise, and wound necrosis or wound dehiscence.

▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
▪ Infection.
▪ Loss of neurologial 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.

▪ 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 device into vertebral body(ies).
▪ Tissue or nerve damage, irritation, and/or pain caused by improper positioning and placement of implants or instruments.

Note: additional surgery may be necessary to correct some of these anticipated adverse events.

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 the results. Use of this product in cervical interbody fusion procedures 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(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.