Capstone Control™ Spinal System M708348B120E Rev. D
2020-10-14
IMPORTANT INFORMATION ON THE CAPSTONE CONTROL™ SPINAL SYSTEM
PURPOSE
This device is a fusion device 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.
DESCRIPTION
The Capstone Control™ Spinal System consists of PEEK cages of various widths and heights, which can be inserted between
two vertebral bodies to give support and correction during 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.
No warranties express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are
specifically excluded.
INDICATIONS
The Capstone Control™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with
Degenerative Disc Disease (DDD) at 1 or 2 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. When used for these indications, the Capstone Control™ Spinal System is
intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Additionally, the Capstone Control™ 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 6 months of nonoperative treatment. The Capstone Control™ Spinal
System is intended 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 when the subject device is used as
an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach.
The 18mm Capstone Control™ Spinal System implant can only be implanted via a Posterior (PLIF) approach. When using the
18mm Capstone Control™ Spinal System implant, a minimum of 2 implants are required per spinal level.
CONTRAINDICATIONS
This device is not intended for cervical spine use. Contraindications include:
▪ Infection local to the operative site.
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Any other condition which would preclude the potential 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.
▪ Osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication since this condition may limit the degree of
obtainable correction and/or the amount of mechanical fixation.
▪ Suspected or documented allergy or intolerance to composite materials.
▪ Any case not needing a fusion.
▪ Any case not described in the indications.
▪ Any patient 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.
▪ Spondylolisthesis unable to be reduced to Grade 1.
▪ Any case where implant components selected for use would be too large or too small to achieve a successful result.
▪ Any case that requires the mixing of metals from two different components or systems.
▪ Any patient having inadequate tissue coverage over the operative site or inadequate bone stock, bone quality, or anatomic
definition.
▪ Any patient 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:
▪ Severe bone resorption.
▪ Osteomalacia.
▪ Severe osteoporosis.
POTENTIAL ADVERSE EVENTS
Adverse effects may occur when the device is used either with or without associated instrumentation. The 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:
▪ Disassembly, bending, or breakage of the device.
▪ Implant migration (e.g. early or late loosening or movement of the device or devices).
▪ Pressure on the surrounding tissues or organs.
▪ Subsidence of the device into vertebral body.
▪ Infection.
▪ Foreign body reaction to the implants including possible tumor formation, autoimmune disease, and scarring.
▪ Discitis, arachnoiditis, and/or other types of inflammation.
▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and
vertebral body) and bone graft or bone graft harvest site at, above, or below the level of surgery.
▪ Bone fracture or stress shielding at, above, or below the level of surgery.
▪ Non-union (or pseudoarthrosis), delayed union, or mal-union.
▪ Retropulsed graft.
▪ Loss of neurological function, appearance of radiculopathy, dural tears, and development of pain, numbness, neuroma,
tingling sensation, sensory loss, and/or spasms.
▪ Neurovascular compromise including paralysis, temporary or permanent retrograde ejaculation in males, dysesthesia,
hyperesthesia, anesthesia, paresthesia, or other types of serious injury.
▪ Scar formation possibly causing neurological compromise or compression around nerves and pain.
▪ Cauda equine syndrome, neuropathy, neurological deficit (transient or permanent), paraplegia, paraparesis, reflex deficits,
arachnoiditis, and/or muscle loss.
▪ Cerebral spinal fluid leakage, pseudomemingocele, fisula, or meningitis.
▪ Tissue or nerve damage, irritation, and/or pain caused by improper positioning and placement of the implants or
instruments.
▪ Hemorrhage of blood vessels and hematomas, occlusion, seroma, edema, embolism, stroke, excessive bleeding, phlebitis,
damage to the blood vessels, or cardiovascular system compromise.
▪ Deep venous thrombosis, thrombophlebitis, and pulmonary embolus.
▪ Herniated nucleus pulposus, disc disruption, or degeneration at, above, or below the level of surgery.
▪ Bone graft donor site complication, including pain, fracture, infection, or poor wound healing.
▪ Wound necrosis or wound dehiscence.
▪ Ileus, gastritis, bowel obstruction, or other types of gastrointestinal system compromise.
▪ Bone loss or decrease in bone density possibly caused by stress shielding.
▪ Loss of proper spinal curvature, correction, height, and reduction.
▪ Loss of spinal mobility.
▪ Urinary retention or loss of bladder control or other types of urological system compromise.
▪ Reproductive system compromise, including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems (e.g. atelectasis, bronchitis, pneumonia, etc.).
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Inability to resume activities of normal daily living.
▪ Change in mental status.
▪ Death.
Note: additional surgery may be necessary to correct some of these anticipated adverse events.
WARNINGS AND PRECAUTIONS
Do not re-use or re-process devices labeled as single use devices. Re-use or re-processing of single use devices may
compromise the structural integrity and the intended function of the device which could result in patient injury.
When used in deformity procedures, undersizing the implant may limit endplate engagement and potentially lead to implant
migration and/or expulsion.
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. This device system is not intended to be the sole means of spinal support. The
Capstone Control™ Spinal System must be used with additional anterior or posterior instrumentation to augment stability. 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(s) will
eventually occur.
Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and correct selection and
placement of the implants are important considerations in the successful use of the system. Final positioning of the implant must
be completed while implant is attached to the Capstone Control™ inserter. Further, proper selection and compliance of the
patient will greatly affect results. Patients who smoke were shown to have a reduced incidence of bone fusion. These patients
should be advised of this fact and warned of this consequence. Obese, malnourished, or alcohol/drug abuse patients, and those
with poor muscle and bone quality and nerve paralysis are also poor candidates for spinal fusion.
Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those patients
without a previous spinal surgery.
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 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, bending, 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 Capstone Control™ Spinal System device. Even when a removed device appears
undamaged, it may have small defects or internal stress patterns that may lead to early breakage.
PREOPERATIVE
▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and predispositions such as those addressed in the contraindications should be avoided.
▪ Care should be taken when handling and storing the device. They should not be scratched or damaged. Devices should be
protected during storage especially from corrosive environments.
▪ The surgeon should be familiar with the various devices before use and should personally verify all implants and necessary
instruments are present before surgery.
▪ The size of device 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.
▪ Additional sterile components should be available in case of any unexpected need.
INTRAOPERATIVE
▪ Instructions in any available Capstone Control™ 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.
▪ When used via a posterior approach, supplemental posterior instrumentation is recommended. Posterior supplemental
fixation is limited to Medtronic posterior instrumentation systems.
▪ 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 the patient, as well as the corresponding patient’s compliance are
extremely important.
▪ Detailed instructions on use and limitations of the device should be given to the patient. The patient must be warned that
loosening and breakage of the device(s) are complications which may occur as result of early or excessive weight-bearing,
muscular activity, or sudden jolts or shock to the spine.
▪ The patient should be advised not to smoke or consume excess alcohol during period of the bone fusion process.
▪ The patient should be advised of the inability to bend at the point of spinal fusion and taught to compensate for this
permanent physical restriction in body motion.
▪ It is important that immobilization of union is established and confirmed by roentgenographic examination. If a non-union
develops or if the components loosen, migrate, or break, the devices should be revised and/or removed immediately before
serious injury occurs.
▪ These implants are interbody devices and are intended to stabilize the operative area during the fusion process.
▪ Retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.
VISUAL INSPECTION
Visually inspect all sterile-barrier packaging before use. If the sterile barrier is damaged or the integrity is compromised, do not
use the product. Contact Medtronic for return information. Visually inspect the device before use. If the device is damaged, do
not use the product. Contact Medtronic for return information.
PACKAGING
Implants are supplied sterile. Packages should be intact upon receipt. Once the seal on the sterile package is broken, the
product should not be re-sterilized. 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
Implants are provided sterile and should only be used if they are marked sterile and clearly labeled as such in an unopened
sterile package provided by Medtronic. Only sterile products should be placed in the operative field.
PRODUCT COMPLAINTS
To report product problems, contact Medtronic.
MRI INFORMATION
MR Conditional
The Capstone Control™ Spinal System was determined to be MR-Conditional based on comparison to previously evaluated
Medtronic products. A patient with this device can be safely scanned immediately after device placement under the following
conditions:
Static Magnetic Field
▪ Static magnetic field of 1.5 and 3.0 Tesla.
▪ Maximum spatial gradient magnetic field of 3000 Gauss/cm (30 T/m) 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 Capstone Control™ Spinal System produced the
following temperature rises during 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 3.0 Tesla/128 MHz (Excite, HDx, Software 14X.M5,
General Electric Healthcare, Milwaukee, WI) MR systems:
Table 1: Temperature Rise During MRI
1.5 Tesla 3.0 Tesla
MR system reported, whole body averaged 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
Capstone Control™ Spinal System. Therefore, optimization of MR imaging parameters to compensate for the presence of this
device may be necessary.
If the Capstone Control™ Spinal System is used in connection with any device which is not MR Conditional, be advised this
combination was not tested in the MR environment and, therefore, higher heating and possible injury to the patient may occur.
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
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
For US audiences only
Sterilized using irradiation
Use-by date
MR Conditional
Consult instructions for use at this website.
Medical device
Single sterile barrier system
Double sterile barrier system
Single sterile barrier system with protective packaging
inside
Single sterile barrier system with protective packaging
outside
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