Neo Medical Ti6Al4V Interbody Fusion Device Owner’s Manual
- July 31, 2024
- Neo Medical
Table of Contents
Ti6Al4V Interbody Fusion Device
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Specifications
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Manufacturer: Neo Medical S.A. and Neo Medical GmbH
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Model: NEO CAGE SYSTEMTM
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Material: Titanium alloy Ti6Al4V
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Intended Use: Stabilization and promotion of bone fusion in
spinal disorders -
Delivery: Sterile and ready to use
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Single Use: Implants and instruments are single-use except for
the Cage Puller
Product Usage Instructions
Purpose and Description
This device is a titanium alloy interbody fusion device designed
for stabilization and bone fusion in spinal disorders. It comprises
titanium alloy cages that can be inserted between lumbar or
lumbosacral vertebral bodies. The hollow geometry allows packing
with bone graft material.
Implantation
The NEO Cage SystemTM should be implanted by a knowledgeable
physician via open surgery using a posterior or transforaminal
approach. The cage should contain bone graft material for interbody
fusion.
Single-Use Policy
All implants and instruments, except the Cage Puller, are for
single use only. Reusing or attempting to re-sterilize them can
lead to risks for the patient, infections, and performance
issues.
Disposal
After use, all instruments must be decontaminated and disposed
of according to local regulations for infectious waste.
FAQ
Q: Can the NEO Cage SystemTM be reused?
A: No, all implants and instruments, except the Cage Puller, are
designed for single use only. Reusing them can pose risks to the
patient’s health.
Q: What is the indication for use of the NEO Cage
SystemTM?
A: The system is intended for Degenerative Disc Disease (DDD) at
one or multiple levels from L2 to S1, confirmed by history and
radiographic studies, in skeletally mature patients who have had
six months of non-operative treatment.
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Ref. IFUCSENG
NEO CAGE SYSTEM TM
Neo Medical S.A. Route de Lausanne 157A 1096 Villette Switzerland
Neo Medical GmbH Gottlieb-Daimler-Str. 6 D-89150 Laichingen Germany
2023-08 V. 3.3
0476
Important Information on the NEO CAGE SYSTEMTM
PURPOSE This device is a titanium alloy Ti6Al4V 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 who is thoroughly
knowledgeable in the implant’s material and surgical aspects and who has been
instructed as to its mechanical and material applications and limitations
DESCRIPTION The NEO Cage SystemTM comprises a variety of sizes of titanium
alloy (Ti-6Al-4V ELI) cages as well as instruments. The cages 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 bone graft material. The cages are
all delivered sterile and ready to use.
The cage system consists of cages which differ in length and height. The
system includes the relevant instruments which are disposable and delivered
sterile with the exception of the Cage Puller which is delivered unsterile and
intended to be reused according to the instruction for use for Non-Sterile
Instrument. All the system components are made of materials compliant with
current ISO and/or ASTM standards. The cages are delivered individually pre-
packed in a protection sleeve. The size and form of the devices is adjusted to
the morphology of the body and the operation technique.
Implants and instruments of the NEO Cage SystemTM with the exception of the
Cage Puller are single use device and should never be reused under any
circumstances.
LIMITED WARRANTY AND DISCLAIMER Neo Medical’s products are sold with a limited
warranty to the original purchaser against defects in workmanship and
materials. Any other express or implied warranties, including warranties of
merchantability or fitness, are hereby disclaimed.
SINGLE USE / DISPOSABLE MEDICAL DEVICES The implants of the NEO Cage SystemTM
are for single use. All instruments of the NEO Cage SystemTM except for the
Cage Puller are for single use as well and fully disposable. It is forbidden
to reuse or to try to re-sterilize any part of the single use devices of the
NEO Cage SystemTM as certain technical characteristics of the system are not
compatible with it. The reuse of any single use part of the system may lead to
a risk for the patient.
An attempt to reprocess, re-clean, re-sterilize and/or disinfect the single
use implants and instrument might lead to infection or toxic reaction.
Furthermore, it may negatively impact the performance and characteristics of
parts of the system.
After the use, all instruments need to be decontaminated and disposed
according to local laws and regulations regarding infectious waste.
For instructions regarding the Cage Puller refer to the instructions for use
for Non-Sterile Instruments.
INDICATIONS EUROPE AND OTHER COUNTRIES EXCEPT USA AND CANADA Neo Cage SystemTM
is intended to be used with bone graft material packaged within the implant to
facilitate interbody fusion and to be used with supplemental spinal fixation
systems that have been cleared for the use in the lumbosacral spine. The cage
is to be implanted in open surgery via a posterior or transforaminal approach.
1 (5)
Ref. IFUCSENG
The indication for use is Degenerative Disc Disease (DDD) at one or multiple
levels from L2 to S1. These DDD patients may also have grade 1 and potentially
grade 2 or 3 Spondylolisthesis 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.
The Instruments are to be used for the implantation of the above mentioned
medical devices.
CONTRAINDICATIONS
Contraindications include, but are not limited to:
· This device is not intended for cervical spine use. · Infection local to the
operative site · Signs of local inflammation · An overweight or obese patient
can produce loads on the spinal system, which can lead to failure of the
fixation of the device or to failure
of the device itself. · Pregnancy · Open wounds · Any mental or neuromuscular
disorder, which would create an unacceptable risk of fixation failure or
complications in postoperative
care · 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 · Any
abnormality present which affects the normal process of bone remodeling
including, but not limited to, severe osteoporosis, osteopenia, primary or
metastatic tumors involving the spine, active infection at the site or certain
metabolic disorders affecting osteogenesis. · Patients with a known hereditary
or acquired bone friability or calcification problem · Suspected or documented
allergy or intolerance to the materials used · Any case not described in the
indications · Any condition of senility, mental illness, or substance abuse.
These conditions, among others, may cause the patient to ignore certain
necessary limitations and precautions in the use of the implant, leading to
failure or other complications. · 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 · Any patient in which implant
utilization would interfere with anatomical structures or expected
physiological performance · Prior fusion at the level to be treated · Any
neuromuscular deficit, which places an unsafe load level on the device during
the healing period
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 but are not limited to:
· 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
2 (5)
Ref. IFUCSENG
· 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
WARNING 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.
Patients with previous spinal surgery at the levels to be treated may have
different clinical outcomes compared to those without a previous surgery.
Do not use any of the NEO Cage SystemTM implant components with components
from any other system or manufacturer unless specifically allowed to do so in
this or another NEO MEDICALTM document.
PRECAUTIONS The implantation of the intervertebral body fusion device should
be performed only by experienced spinal surgeons with specific training in the
use of this device because this is a technically demanding procedure
presenting a risk of serious injury to the patient.
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 utilization of the
system by the surgeon. Further, the proper selection and the compliance of the
patient will greatly affect the results. The physician should consider the
levels of implantation, patient weight, patient activity level, other patient
conditions, etc., which may impact on the performance of the intervertebral
body fusion device. 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.
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.
PREOPERATIVE · Only patients that meet the criteria described in the
indications section should be selected. · Patient conditions and/or
predispositions such as those addressed in the aforementioned
contraindications should be avoided. · Care should be used in the handling and
storage of the implant components. The implants should not be scratched or
otherwise
damaged. Implants and instruments should be protected during storage. · The
size of device for the case should be determined prior to beginning the
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. · Since mechanical parts are involved, the surgeon
should be familiar with the various components before using the equipment and
should
personally verify that the necessary items are available before the surgery.
The NEO Cage SystemTM components (described in the DESCRIPTION section) are
not to be combined with the components from another manufacturer. · Additional
components should be available in case of an unexpected need.
INTRAOPERATIVE · The instructions in the Neo Cage SystemTM surgical technique
should be carefully followed. · Extreme caution should be used around the
spinal cord and nerve roots. Damage to the nerves will cause loss of
neurological functions.
3 (5)
Ref. IFUCSENG
· Breakage, slippage, or misuse of instruments or implant components 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. ·
Utilize an imaging system to facilitate surgery.
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 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
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. · Neo Cage SystemTM
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. As
with all orthopedic implants, the NEO Cage SystemTM components must not be
reused under any circumstances. · Non-clinical testing and MRI simulations
were performed to evaluate the entire family of the Neo Cage SystemTM. Non-
clinical testing demonstrated that the entire family of the Neo Cage SystemTM
is MR Conditional. A patient with an implant from this family can be scanned
safely in an MR system under the following conditions:
– Static magnetic field of 1.5-Tesla and 3-Tesla, only – Maximum spatial
gradient magnetic field of 4,000-gauss/cm (40-T/m) – Maximum MR system
reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15
minutes of scanning (i.e.,
per pulse sequence) in the Normal Operating Mode – Under the scan conditions
defined, the Neo Cage SystemTM is expected to produce a maximum temperature
rise of 1.7°C after
15-minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the Neo Cage SystemTM
extends approximately 12-mm from this device when imaged using a gradient echo
pulse sequence and a 3-Tesla MR system.
REVISION If fusion / bone graft growth occurs, the device will be deeply
integrated into the bony tissues. As a result, the Neo CageTM is not intended
to be removed unless the management of a complication or adverse event
requires the removal. Any decision by a physician to remove the device should
take into consideration such factors as: · The risk to the patient of the
additional surgical procedure as well as the difficulty of removal. ·
Migration of the implant, with subsequent pain and/or neurological, articular
or soft tissue lesions · Pain or abnormal sensations due to the presence of
the implants · Infection or inflammatory reactions · Reduction in bone density
due to the different distribution of mechanical and physiological stresses and
strains.
PACKAGING Sterile components of the NEO Cage SystemTM are ready to use, the
contents are sterile unless the package is damaged, opened, or the expiration
date on the device label has passed. For non-sterile components of the NEO
Cage SystemTM please refer to the instruction for use for non-sterile
instruments.
Caution: Packages for each of the components should be intact upon receipt.
All boxes should be carefully checked to ensure that there is no damage prior
to use. Damaged packages or products should not be used, and should be
returned to the local distributor or to NEO MEDICAL S.A.
Caution: Before use the product expiration date must always be checked and not
used if expired.
PRODUCT COMPLAINTS Any health care professional (e.g., customer or user of
this system of products) who has any complaints or who has experienced any
dissatisfaction in the product quality, identity, durability, reliability,
safety, effectiveness and/or performance, should notify the official
distributor of NEO MEDICAL S.A.). Further, if any of the implanted spinal
system component(s) ever “malfunctions” (i.e., does not meet any of its
performance specifications or otherwise does not perform as intended), or is
suspected of doing so, the distributor should be notified immediately. If any
NEO MEDICAL S.A. product ever “malfunctions” and may have caused or
contributed to the death or serious injury of a patient, the distributor
should be notified immediately by telephone, FAX, or written correspondence.
When filing a complaint, please provide the component(s) name and number, lot
number(s), your name and address, the nature of the complaint, and
notification of whether a written report from the distributor is requested.
4 (5)
Ref. IFUCSENG
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 NEO MEDICAL S.A.
EXPLANATION OF SYMBOLS
Manufacturer
European Authorized Representative CAUTION: Federal Law (USA) restricts these
devices to sale by or on the order of a licensed practitioner Unique Device
Identification
Consult instructions for use
Do not re-use
Caution / Warning
Temperature limit
Do not use if package is damaged
Date of manufacture
The device complies with European 0476 Directive MDD 93/42 EEC
Importer in the EU Catalogue Number Lot number Medical Device Sterilized using
irradiation Use by date MR Conditional Keep dry
Double Sterile Barrier
5 (5)