Clydesdale™ Spinal System 0381486E Rev. B
2018-10-29
IMPORTANT INFORMATION ON THE CLYDESDALE™ SPINAL SYSTEM
PURPOSE
This device is a PEEK (polyetheretherketone) interbody 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.
DESCRIPTION
The Clydesdale™ Spinal System consists of PEEK cages of various widths and heights, which include tantalum markers. These
devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar
interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.
No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use
are specifically excluded.
INDICATIONS
The Clydesdale™ Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is
intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Clydesdale™ Spinal System is
used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous 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 6 months of non-operative treatment. These implants may be implanted via a minimally invasive lateral
approach.
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 the 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 or quality.
▪ Any patient in which implant utilization 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 potential 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/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.
▪ 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 or 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 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 AND PRECAUTIONS
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 bone graft 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 the implants are important considerations in the successful use of the system by the surgeon. Further, the proper
selection and the compliance of the patient will greatly affect the results. Patients who smoke have been shown to have a
reduced incidence of bone fusion. These patients should be advised of this fact and warned of this consequence. Obese,
malnourished, and/or alcohol/drug abuse patients and those with poor muscle and bone quality and/or 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.
Do not re-use or re-process devices labeled as single use devices. Re-use or re-processing of a single use device may
compromise the structural integrity and the intended function of the device and/or create a risk of contamination of the device,
which could result in patient injury, illness, or death.
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.
For US Audiences Only
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
IMPLANT SELECTION
The selection of the proper size, shape, and design of the implant for each patient is crucial to the 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 Clydesdale™ 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/or predispositions such as those addressed in the aforementioned contraindications should be
avoided.
▪ Care should be taken in the handling and storage of 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.
▪ All devices should be sterilized before use. Additional non-sterile components should be available in case of any
unexpected need.
INTRAOPERATIVE
▪ The instructions in any available Clydesdale™ 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 the 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 graft must be used.
▪ Bone cement should not be used because this material may make removal of these components difficult or impossible. The
heat generated from the curing process may damage or deform the PEEK devices.
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. The patient must be warned
that loosening, and/or 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 the 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, and/or break, the devices should be revised and/or removed immediately
before serious injury occurs.
▪ Clydesdale™ Spinal System implants are interbody devices and are intended to stabilize the operative area during the
fusion process.
▪ Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.
PACKAGING
These devices are supplied in a non-sterile form. Packages for each of the components should be intact upon receipt. Once the
seal on the package has been broken, the product should be sterilized prior to use. Damaged packages or products should not
be used and should be returned to Medtronic.
STERILIZATION
All implants used in surgery must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization.
The non-sterile products are recommended to be steam sterilized by the hospital using one of the sets of process parameters
listed in Table 1.
Table 1: Sterilization Parameters
Method Cycle Temperature Exposure time
Steam Dynamic-air-removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 275°F (135°C) 3 Minutes 30 Minutes
Minimum dry time
1
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 end 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 Food and Drug Administration (FDA) for the selected sterilization cycle specifications (time and
temperature).
1
The 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.
MRI INFORMATION
MR Conditional
The Clydesdale™ 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 Tesla and 3.0 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 Clydesdale™ Spinal System 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:
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˚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
Clydesdale™ Spinal System. Therefore, optimization of MR imaging parameters to compensate for the presence of this device
may be necessary.
MRI Patient Counseling Information
Physicians should communicate with the patient of the following information about MRI with respect to the Clydesdale™ Spinal
System:
▪ Clydesdale™ Spinal System performance has been established for MRI systems at field strengths of 1.5 Tesla and 3.0
Tesla.
▪ 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 non-clinical
testing was +1.8ºC (associated with specific conditions previously listed).
▪ 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 the image distortion.
Physicians should instruct patients to:
▪ Inform any healthcare personnel (e.g., doctor or MR technologist) that they have an implanted interbody device prior to
receiving an MRI.
▪ The patient’s doctor will recommend whether or not an MRI is appropriate.
If the Clydesdale™ Spinal System is used in connection with any device which is not MR Conditional, be advised this
combination has not been tested in the MR environment and, therefore, higher heating and possible injury to the patient may
occur.
PRODUCT COMPLAINTS
For 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 needed or required, please contact Medtronic.
©2018 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
Non-sterile
For US audiences only
Consult instructions for use at this website.
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