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3993214
Instructions for Use
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Medtronic 3993214 Instructions for Use

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Capstone PTC™ Spinal System M708348B425E Rev. C
2020-04-01
IMPORTANT INFORMATION ON THE CAPSTONE PTC™ 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
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 PTC™ Spinal System is indicated for interbody fusion 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 levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment.
Additionally, the Capstone PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.
These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are 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. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.
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.
▪ 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:
▪ Implant migration. ▪ Breakage of the device(s). ▪ Foreign body reaction to the implants including possible tumor formation, auto immune disease, and scarring. ▪ Pressure on the surrounding tissues or organs. ▪ Loss of proper spinal curvature, correction, height, and 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 development of pain, numbness, neroma,
tingling sensation, sensory loss, and/or spasms.
▪ 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.
▪ Retropulsed graft. ▪ 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 hematomas. ▪ Discitis, arachnoiditis, and or other types of inflammation. ▪ Deep venous thrombosis, thrombophlebitis, and pulmonary embolus. ▪ Bone graft donor site complication. ▪ Inability to resume activities of normal daily living. ▪ Early or late loosening or movement of the device(s). ▪ Urinary retention,loss of bladder control, or other types of urological system compromise. ▪ Scar formation possibly causing neurological compromise or compression around nerves and pain. ▪ 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.
▪ 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 AND PRECAUTIONS
A device that has been implanted should never be reused or reprocessed under any circumstances. Sterile packaged devices should also never be resterilized. Reuse or reprocessing may compromise the structural integrity of implants and create a risk of contamination which could result in patient injury, illness, or death.
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. 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 or in cases that do not develop a union will not be successful.
Preoperative and operating procedures including knowledge of surgical techniques, good reduction, and correct selection and placement of implants are important considerations in the successful use of the system. 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 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 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 PTC™ 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(s). 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 devices 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.
▪ Unless supplied sterile, all devices should be cleaned and sterilized before use. Additional sterile components should be
available in case of any unexpected need.
INTRAOPERATIVE
▪ Instructions in any available Capstone PTC™ 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 the 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 the 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 weight­bearing, 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.
▪ Capstone PTC™ Spinal System 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.
PACKAGING
Devices may be supplied sterile or non-sterile. Packages for each of the components should be intact upon receipt. Once the seal on the sterile package is broken, the product should not be resterilized. 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.
CLEANING AND DECONTAMINATION
Specific types of instruments, such as inserters, may have reprocessing instructions enclosed within the product packaging. Refer to these detailed instructions for further information on the general considerations, cleaning, and sterilization procedures. These reprocessing instructions can also be found at http://manuals.medtronic.com/ according to the product part number.
STERILIZATION
Unless marked sterile and clearly labeled as such in an unopened sterile package provided by Medtronic, all implants and instruments 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 parameters in Table 1.
Table 1: Sterilization cycle parameters for the US and its territories
Method Cycle Temperature Exposure time
Steam Gravity displacement 250°F (121°C) 30 Minutes 30 Minutes Steam Gravity displacement 270°F (132°C) 15 Minutes 30 Minutes Steam Gravity displacement 275°F (135°C) 10 Minutes 30 Minutes 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: 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. It is the user’s responsibility to use only sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical
indicators, biological indicators, and sterilization cassettes) cleared by the FDA for the selected sterilization cycle specifications (time and temperature).
Specific types of instruments, such as inserters, may have processing instructions enclosed within the product packaging. Refer to these detailed instructions for further information on the general considerations, cleaning, and sterilization procedures. These reprocessing instructions can also be found at http://manuals.medtronic.com/ according to the product part number.
Minimum dry time
1
MRI INFORMATION
The Capstone PTC™ Spinal System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the Capstone PTC™ Spinal System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
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
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
Batch code
Manufacturer
Catalogue number
Non-sterile
For US audiences only
Sterilized using irradiation
Use-by date
Consult instructions for use at this website.
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