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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.
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▪ 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.
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Further, proper selection and compliance of the patient will greatly affect results. Patients who smoke have 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 given in this document should be conveyed to the patient.
This device was designed for single patient use only. Do not reprocess or reuse this product. Reuse or reprocessing may
compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient
injury, illness, or death.
For US audiences only
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Based on fatigue testing results, when using the Cornerstone
implantation, patient weight, patient activity level, other patient conditions, etc., which may impact performance of this system.
™
PSR Cervical Interbody Fusion Device, consider the levels of
IMPLANT SELECTION
Selection of proper size, shape, and design of the implant for each patient is crucial to 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 human
anatomy. Unless great care is taken in patient selection, placement of the implant, and postoperative management to minimize
stresses on the implant, such stresses may cause material fatigue and consequent breakage or loosening of the device before
the fusion process is complete which may result in further injury or the need to remove the device prematurely.
DEVICE FIXATION
Installation and positional adjustment of implants must only be done with special ancillary instruments and equipment supplied
and designated by Medtronic. In the interests of patient safety, it is therefore recommended that Medtronic implants are not
used with devices from any other source.
Never, under any circumstances, reuse a Cornerstone
appears undamaged, it may have small defects or internal stress patterns that may lead to early breakage.
™
PSR Cervical Interbody Fusion Device . Even when a removed device
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 contraindications should be avoided.
▪ Care should be used when handling and storing implant components. Implants should not be scratched or damaged.
Implants 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.
▪ 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.
▪ This device is provided sterile. Additional sterile components should be available in case of an unexpected need.
INTRAOPERATIVE
▪ The instructions in any available applicable 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 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 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 in all procedures. 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 placed in the area to
be fused and graft material must extend from the upper vertebrae to the lower vertebrae being fused.
▪ Bone cement should not be used since this material will make removal of components difficult or impossible. Heat
generated from the curing process may also cause neurologic damage and bone necrosis.
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 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 otherwise unable to use crutches or other weight supporting devices. The patient
should be warned to avoid falls or sudden jolts in spinal position.
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▪ To allow the maximum chances for a successful surgical result, the patient or device 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. Also, the patient should
be advised not to smoke or consume excess 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. 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, they should be revised and/or removed immediately before serious injury occurs.
▪ Retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.
PACKAGING
Packages for each of the components should be intact upon receipt. If a loaner or consignment system is used, all sets should
be carefully checked for completeness and all components including instruments should be carefully checked to ensure there is
no damage prior to use. Damaged packages or products should not be used, and should be returned to Medtronic.
STERILIZATION
Cornerstone™ PSR Cervical Interbody Fusion Device is provided sterile via gamma irradiation.
Only sterile products should be placed in the operative field. Unless marked sterile and clearly labeled as such in an unopened
sterile package provided by the company, all implants and instruments used in surgery must be sterilized by the hospital prior to
use. The instruments used with this device are provided non-sterile. Refer to the Reusable Instruments used with Cornerstone
PSR Spinal Systems package insert, M708348B089, for sterilization parameters and requirements.
Always immediately clean and re- sterilize instruments used in surgery. This process must be performed before handling or (if
applicable) before returning to Medtronic.
MRI INFORMATION
™
MR Conditional
The Cornerstone
previously evaluated Medtronic products. A patient with this device can be safely scanned immediately after device placement
under the following conditions.
Static Magnetic Field
™
PSR Cervical Interbody Fusion Device was determined to be MR Conditional based on comparison to
▪ 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, a worst case interbody device representative of the Cornerstone
produced the following temperature rises 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 systems:
MR system reported, whole body average SAR 2.9 W/kg 2.9 W/kg
Calormetry Measured values, whole body averaged SAR 2.1 W/kg 2.7 W/kg
Highest temperature change 1.8˚C1.7˚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
Cornerstone
presence of this device may be necessary.
MRI Patient Counseling Information
Physicians should communicate with the patient the following information about MRI with respect to the Cornerstone
Cervical Interbody Fusion Device.
Cornerstone
3.0 Tesla.
™
PSR Cervical Interbody Fusion Device. Therefore, optimization of MR imaging parameters to compensate for the
™
PSR Cervical Interbody Fusion Device performance was established for MRI systems at field strengths of 1.5 and
™
PSR Cervical Interbody Fusion Device
1.5 Tesla 3 Tesla
™
PSR
▪ 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).
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▪ 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 any healthcare personnel (e.g. doctor or MR technologist) that 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 Cornerstone
be advised this combination was not tested in the MR environment and, therefore, higher heating and possible injury to the
patient may occur.
™
PSR Cervical Interbody Fusion Device is used in connection with any device which is not MR Conditional,
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.
©2020 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
Authorized representative in the European Community
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
Sterilized using irradiation
Use-by date
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
For US audiences only
This device complies with applicable European Union
regulations and directives.
MR Conditional
Consult instructions for use at this website.
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