Neo Medical Ti6Al4V Interbody Fusion Device Owner’s Manual

Ti6Al4V Interbody Fusion Device

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Specifications

• Manufacturer: Neo Medical S.A. and Neo Medical GmbH

• Model: NEO CAGE SYSTEMTM

• Material: Titanium alloy Ti6Al4V

• Intended Use: Stabilization and promotion of bone fusion in
  spinal disorders

• Delivery: Sterile and ready to use

• 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.
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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
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· 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.
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· 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.
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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

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