Medtronic 6680825 Instructions for Use

Crescent™ Spinal System Titanium M708348B058E Rev. C

2020-10-02

IMPORTANT INFORMATION ON THE CRESCENT™ SPINAL SYSTEM TITANIUM

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 Crescent™ Spinal System Titanium consists of implant grade titanium alloy (Ti-6Al-4V) cages of various widths and heights
which 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. Implants may be implanted via a transforaminal or lateral approach and the procedure may be open or minimally
invasive.

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

INDICATIONS

The Crescent™ Spinal System Titanium 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 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. 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 Medtronic supplemental fixation instrumentation cleared by the 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.
▪ Cases not needing a fusion.
▪ Cases not described in the indications.
▪ Patients 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.
▪ Cases where implant components selected for use would be too large or too small to achieve a successful results.
▪ Cases requiring mixing of metals from two different components or systems.
▪ Patients having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Patients 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. 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 device.
▪ Foreign body reaction to 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.
▪ Haemorrhage 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 device.
▪ Urinary retention, 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, 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, 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, bronchitis, pneumonia, etc.).
▪ Change in mental status.
▪ Cessation of potential growth of the operated portion of the spine.
▪ Death.

WARNINGS AND PRECAUTIONS

Do not re-use or re-process devices labeled as single use devices. Reuse or reprocessing may compromise the structural
integrity of a single use device and/or create a risk of contamination of the device, which could result in patient injury, illness, or
death. 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 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 the
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.

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 Crescent™ Spinal System Titanium 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

▪ Static magnetic field of 1.5 Tesla 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.

Under the scan conditions defined, a worst-case interbody fusion device representative of the Crescent™ Spinal System
Titanium produced a maximum temperature rise of less than 5.0 °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 Crescent™ Spinal
System Titanium extends approximately 13 mm for a spin echo sequence and 23 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.

If Crescent™ Spinal System Titanium 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
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 Crescent™ Spinal System Titanium 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 devices. 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 Crescent™ Spinal System Titanium 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. This material may make removal of components difficult or impossible.

POSTOPERATIVE

The physician’s postoperative directions and warnings to the patient and the corresponding patient 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/or breakage of 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 components loosen, migrate, and/or break, devices should be revised and/or removed immediately before
serious injury occurs.

▪ Crescent™ Spinal System Titanium 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

Packages for devices 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.

CLEANING

Disassembly instructions and detailed cleaning instructions can be found at http://manuals.medtronic.com/. Refer to the
“Reprocessing Instructions for the Crescent™ Spinal System Titanium Instruments – M708348B064” for disassembly, cleaning
and sterilization instructions specific to the inserter (p/n: outer shaft 6660000 & inner shaft 6660004) and Trials (p/n
6680725/1625, 6682507/2516, 6682507/2516, 9590725/1625, 9592507/2516, 6680730/1630, 6683007/3016, 9503007/3016,
9500730/1630, 6680736/1636, 6683607/36163590736/1636, 9593607/3616) instruments.

STERILIZATION

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. 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

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: chamber size and chamber load differences may exist between industrial and health care facility sterilizer models. The

sterilization parameters listed in Tables 1 and 2 can be achieved in both health care facility and larger, industrial sterilizer
models. 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.

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 (e.g. 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
Crescent™ Spinal System Titanium Instruments – M708348B064” for disassembly, cleaning and sterilization instructions
specific to the inserter (p/n: outer shaft 6660000 & inner shaft 6660004) and Trials (p/n 6680725/1625, 6682507/2516,
6682507/2516, 9590725/1625, 9592507/2516, 6680730/1630, 6683007/3016, 9503007/3016, 9500730/1630, 6680736/1636,
6683607/36163590736/1636, 9593607/3616) instruments.

Minimum dry time

Minimum dry time

1

1

SERVICING

Inspect all instruments prior to use. Return devices to Medtronic if any of the following are observed: corrosion, discoloring,
pitting, or any other signs of wear.

Inspect the threaded shaft of the instrument. Return these devices to Medtronic if threads are damaged or distorted or if the
shaft appears bent.

Inspect the silicone handle of the instrument. Return these devices to Medtronic if the silicone handle is discolored, cut, or
damaged in any way.

PRODUCT COMPLAINTS

To report any 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.

This device complies with applicable European Union
regulations and directives.

This device complies with applicable European Union
regulations and directives.

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

For US audiences only

Non-sterile

Sterilized using irradiation

Use-by date

Consult instructions for use at this website.

MR Conditional