Medtronic 4920040 Instructions for Use

Clydesdale PTC™ Spinal System M708348B427E Rev. B

2020-10-13

IMPORTANT INFORMATION ON THE CLYDESDALE PTC™ SPINAL SYSTEM

PURPOSE

This device is a commercially pure titanium (CP Ti) coated PEEK (polyetheretherketone) interbody 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 Clydesdale PTC™ Spinal System consists of commercially pure titanium (CP Ti) coated 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 and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or
demineralized allograft bone with bone marrow aspirate.

Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

INDICATIONS

The Clydesdale PTC™ Spinal System is designed 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 to facilitate
interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Clydesdale
PTC™ 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 six 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.
▪ Pediatric cases or 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 or quality.
▪ 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/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 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 the 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, 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.

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 these implants and create a
risk of contamination 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 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.

MRI INFORMATION

MR Conditional

The Clydesdale PTC™ Spinal System was determined to be MR-Conditional based on non-clinical testing and engineering
rationales. A patient with this device can be safely scanned immediately after device placement under the following conditions:

▪ 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 under normal operating mode for 15 minutes of

scanning per pulse sequence.

Under the scan conditions defined, a worst-case interbody fusion device representative of the Clydesdale PTC™ Spinal System
produced a maximum temperature rise of 4.4 °C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by a worst-case interbody fusion device representative of the Clydesdale
PTC™ Spinal System extends approximately 20 mm for a gradient echo sequence in a 3-Tesla MR system. Therefore,
optimization of MR imaging parameters to compensate for the presence of this device may be necessary.

Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
If Clydesdale PTC™ Spinal System is used in connection with any device which is not MR Conditional, please be advised that

this combination has not been tested in the MR environment and, therefore, higher heating and possible injury to the patient
may occur. The presence of other implants or the health state of the patient may require a modification of the MR conditions.

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 Clydesdale 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/or predispositions such as those addressed in the contraindications should be avoided.
▪ Care should be taken when handling and storing 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.

▪ 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

▪ The instructions in any available Clydesdale 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.

▪ 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 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 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 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.

CLEANING

Disassembly/reassembly and cleaning instructions can be found at http://manuals.medtronic.com/. Refer to the “Reprocessing
Instructions for the Lateral Inserters– M708348B087” for disassembly and cleaning instructions specific to the DL Inserter
instrument (part number 2942001). Refer to the “Important Information for Medtronic Reusable Instruments - 0380035”for
cleaning instructions for Clydesdale PTC™ Spinal System trials.

STERILIZATION

Unless marked sterile and clearly labeled as such in an unopened sterile package provided by Medtronic, 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

Minimum dry time

1

For medical facilities located outside the US and its territories: some non-US health care authorities recommend sterilization
according to these parameters to minimize the risk of transmission of Creutzfeldt-Jakob disease, especially of surgical
instruments that could come into contact with the central nervous system.

Table 2: Sterilization cycle parameters for medical facilities outside the US and Its Territories

Method Cycle Temperature Exposure time

Steam Gravity displacement 273°F (134°C) 20 Minutes 30 Minutes
Steam Dynamic-air-removal 273°F (134°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 273°F (134°C) 20 Minutes 30 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, exposure times) used for their equipment.
The sterilization cycles listed in Table 2 are not considered by the Food and Drug Administration (FDA) to be standard

sterilization cycles. 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).

Sterilization instructions can be found at http://manuals.medtronic.com/. Refer to the “Reprocessing Instructions for the Direct
Lateral (DL) Inserter– M708348B087” for the sterilization instructions specific to the DL Inserter instrument (part number

2942001). Refer to the “Reprocessing Instructions for the General Instruments” 0380035 for sterilization instructions for
Clydesdale PTC™ Spinal System trials.

Minimum dry time

1

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: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

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.

Consult instructions for use at this website.

Do not re-use

Batch code

Manufacturer

Catalogue number

Medtronic B.V.

Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00

Non-sterile

For US audiences only

This device complies with applicable European Union
regulations and directives.

Sterilized using irradiation

Use-by date

MR Conditional