ORTHOFIX M6-L Artificial Lumbar Disc Instructions

ORTHOFIX M6-L Artificial Lumbar Disc

Intended Use

The M6-L™ Artificial Lumbar Disc is an intervertebral disc prosthesis intended to maintain motion of a functional spinal unit in the lumbar spine when the native disc is diseased.

Device Description

The M6-L Artificial Lumbar Disc is an intervertebral disc prosthesis designed to permit motion of a functional spinal unit in the lumbar spine when replacing a degenerated native disc. The device is comprised of an assembly of ultra-high molecular weight polyethylene (UHMWPE) fiber wound in a specific pattern, with multiple redundant layers, creating a fiber matrix (artificial annulus). The fiber is wound around a polycarbonate urethane polymer (PCU) core (artificial nucleus) and through the slots in two Ti6Al4V titanium alloy endplates. The core is situated between and in contact with the two endplates, but not affixed to them. A PCU sheath surrounds the fiber matrix and is retained by two Ti6Al4V weld rings that are welded to the endplates. Two Ti6Al4V lids are also welded to the endplates. The exterior surfaces of the lids include low profile fins and are coated with titanium plasma spray (TPS).

The M6-L Artificial Lumbar Disc is designed to maintain the natural behavior of a functional spinal unit by replicating the biomechanical characteristics of the native disc. This design enables the M6-L Artificial Lumbar Disc to move in all six degrees of freedom, with independent angular rotations (flexion- extension, lateral bending and axial rotation) along with independent translational motions (anterior-posterior and lateral translations as well as axial compression). The device is intended to replicate the physiological phenomenon of progressive resistance to motion in all six degrees of freedom. The sheath is designed to minimize any tissue ingrowth as well as the migration of wear debris. The serrated fins provide acute fixation to the superior and inferior vertebral bodies. The TPS coating increases bone contact surface area.
To accommodate the various anatomical ranges, the M6-L Artificial Lumbar Disc is available in a variety of angles and endplate footprints.

| Description| Provided Sterile
---|---|---
LDM-1003| Lumbar Disc – 10 Medium 3°
(10mm H x 35mm W x 27mm D, 3° Lordosis)| Yes
LDM-1006| Lumbar Disc – 10 Medium 6°
(10mm H x 35mm W x 27mm D, 6° Lordosis)| Yes
LDM-1010| Lumbar Disc – 10 Medium 10°
(10mm H x 35mm W x 27mm D, 10° Lordosis)| Yes
LDM-1016| Lumbar Disc – 10 Medium 16°
(10mm H x 35mm W x 27mm D, 16° Lordosis)| Yes
LDL-1003| Lumbar Disc – 10 Large 3°
(10mm H x 39mm W x 30mm D, 3° Lordosis)| Yes
LDL-1006| Lumbar Disc – 10 Large 6°
(10mm H x 39mm W x 30mm D, 6° Lordosis)| Yes
LDL-1010| Lumbar Disc – 10 Large 10°
(10mm H x 39mm W x 30mm D, 10° Lordosis)| Yes
LDL-1016| Lumbar Disc – 10 Large 16°
(10mm H x 39mm W x 30mm D, 16° Lordosis)| Yes
LDM-1203| Lumbar Disc – 12 Medium 3°
(12mm H x 35mm W x 27mm D, 3° Lordosis)| Yes
LDM-1210| Lumbar Disc – 12 Medium 10°
(12mm H x 35mm W x 27mm D, 10° Lordosis)| Yes
LDL-1206| Lumbar Disc – 12 Large 6°
(12mm H x 39mm W x 30mm D, 6° Lordosis)| Yes
LDL-1210| Lumbar Disc – 12 Large 10°
(12mm H x 39mm W x 30mm D, 10° Lordosis)| Yes
LDXL-1006| Lumbar Disc – 10 Extra Large 6°
(10mm H x 44mm W x 33mm D, 6° Lordosis)| Yes
LDXL-1010| Lumbar Disc – 10 Extra Large 10°
(10mm H x 44mm W x 33mm D, 10° Lordosis)| Yes
LDXL-1016| Lumbar Disc – 10 Extra Large 16°
(10mm H x 44mm W x 33mm D, 16° Lordosis)| Yes

IndicatIons for Use

The M6-L Artificial Lumbar Disc System is intended for use in skeletally mature patients undergoing primary surgery for treatment of symptomatic degenerative disc disease (DDD) of the lumbar spine at any one level or two adjacent levels between L3 through S1, who have not responded to at least 6 months of non-operative, conservative management. The DDD patient may also have up to 3mm of spondylolisthesis at the involved level. The disease state is demonstrated by signs and/or symptoms of disc herniation, osteophyte formation, or loss of disc height.

Contraindications

The M6-L Artificial Lumbar Disc should not be implanted in patients with the following conditions:

• Be >75 years of age, or < 18 years of age
• Osteopenia or osteoporosis defined as a bone mineral density with T-score ≤-1.5 as determined by spine DXA if male ≥ 60 years of age or female ≥50 years of age
• Have an active systemic infection or infection at the operative site
• Have sustained an osteoporotic fracture of the spine, hip or wrist
• Have received medications (e.g. methotrexate, alendronate) that interfere with bone and mineral metabolism within 2 weeks of the planned date of the index surgery
• Have a history of endocrine or metabolic disorders (e.g., Paget’s disease) known to affect bone and mineral metabolism
• Have rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV or active hepatitis
• Prior intra-abdominal or retroperitoneal surgery that would make the approach prohibitively dangerous
• Prior anterior surgery at the same level
• Spinal metastases
• Have a known allergy to titanium, polyurethane, polyethylene or ethylene oxide residuals
• Have uncontrolled insulin dependent type 1 or type 2 diabetes
• Require a treatment (e.g., posterior element decompression) that destabilizes the spine
• Bony lumbar stenosis
• Isolated radicular compression syndromes, especially due to disc herniation
• Pars defect
• Increased segmental instability
• Spinal deformities, spondylolisthesis above 3mm at the involved level(s)
• Radiological confirmation of severe facet joint disease or degeneration
• Have advanced degenerative changes at the index vertebral level
• Preoperative remaining disc height < 3mm precautions
• Read and understand the M6-L Artificial Lumbar Disc System Instructions for Use prior to use.
• The M6-L Artificial Lumbar Disc is intended to be used with the M6-L Manual Surgical Instruments.
• Refer to the M6-L Artificial Lumbar Disc Operative Technique Manual for implantation instructions.
• The M6-L Artificial Lumbar Disc System is intended to be used only by surgeons with training in lumbar spine surgery and related surgical techniques, and biomechanical principles of the spine and spine arthroplasty.
• Prior to use, the surgeon must be trained in the surgical procedure as outlined in the M6-L Artificial Lumbar Disc Operative Technique Manual and thoroughly familiar with the implant and instruments.
• Improper surgical use and technique may lead to suboptimal clinical outcomes.
• Do not use the M6-L Artificial Lumbar Disc after the last day of the month of the “Use by date” on the label.
• Inspect the device package before opening. Do not use if package is damaged or shows any evidence of breached packaging, compromised device sterility, or storage above 60°C (140°F). The temperature recorder label on the box turns black if the product has reached 60°C (140°F).
• Use sterile technique to carefully remove the disc from the packaging. Inspect the M6-L Artificial Lumbar Disc to ensure it exhibits no signs of damage (e.g., metal and plastic damage).
• The M6-L Artificial Lumbar Disc must be implanted using the M6-L Manual Surgical Instruments only. The use of the M6-L Manual Surgical Instruments for purposes other than those for which they are intended may result in damaged or broken instruments. Do not use any other implant components or instrumentation.
• The M6-L Artificial Lumbar Disc serial number and the size must be documented for each patient record.
• The manufacturer is not responsible for any complications arising from incorrect diagnosis, choice of incorrect M6-L Artificial Lumbar Disc, incorrect surgical techniques, including improper use of instruments, the limitations of treatment methods, or inadequate asepsis.
• The surgeon should instruct the patient on postoperative rehabilitation and limitations. Postoperative care and the patient’s ability and willingness to follow instructions are two of the most important aspects of successful osseointegration of the implant. The patient must be made aware of the limitations of the implant and that early strenuous physical activity and high load bearing have been implicated in premature loosening of fixation prior to proper integration. An active, debilitated, or uncooperative patient who cannot properly restrict activities may be at particular risk during postoperative rehabilitation.
• Certain activities should be limited or avoided for two weeks postoperatively. It is recommended that the surgeon discuss with the patient the following limitations:
  • Excessive low back movements: Short term use of a lumbar sacral orthosis (LSO) to stabilize the low back and reduce excess movement is an option. Instruct patient to avoid excessive flexion/extension for two weeks postoperative.
  • Heavy lifting: Avoid lifting anything heavier than about 3.5-4.5 kilograms (8-10 pounds) for two weeks postoperative.
  • Returning to work: In general, return to light work, such as a desk job or school, approximately one week after surgery. Returning to a more physical job, such as construction, may take six weeks or longer.
  • Resuming sports and other physical activities: The timeline for returning to sports and other recreational activities can vary. The weight permitted for lifting may gradually increase starting after two weeks. Some light sport activities may be permitted at about 4 weeks, such as jogging, biking, or swimming. A return to competitive sports may take 6 weeks or longer, depending on the integration of the device and the ability to perform the sport’s movements pain-free. There is currently a lack of data regarding lumbar artificial discs and contact or extreme sports.
• Physicians should instruct patients to contact surgeon in the event of significant increase in pain which may indicate a device performance issue.

Warnings

• Correct placement of the M6-L Artificial Lumbar Disc device is essential to optimal performance.
• The M6-L Artificial Lumbar Disc should only be used by surgeons who are experienced in the surgical procedure and have undergone adequate training with this device. A lack of adequate experience and/or training may lead to a higher incidence of adverse events, such as vascular or neurological complications.
• The M6-L Artificial Lumbar Disc is supplied sterile and is single use only. Do not re-sterilize or reuse the M6-L Artificial Lumbar Disc. Re-sterilizing and/or reusing the M6-L Artificial Lumbar Disc may result in impaired performance and could cause patient injury and/or the communication of infectious diseases between patients.
• The M6-L Manual Surgical Instruments are reusable, supplied non-sterile and must be sterilized in accordance with the recommended cleaning and sterilization procedures contained within the individual instrument Instructions for Use booklet.
• During implantation, the surgeon should ensure that none of the surgical instruments or the M6-L Artificial Lumbar Disc progress beyond the posterior border of the vertebral bodies. Due to the proximity of vascular and neurological structures to the implantation site, there are risks of serious or fatal hemorrhage and risks of neurological damage with the use of this device and allowing the instruments or the M6-L Artificial Lumbar Disc to progress beyond the posterior border of the vertebrae may result in injury to these structures.
• Fluoroscopic confirmation of positioning of certain instruments and the implant should be performed during the surgical procedure. Failure to confirm position of instruments and the implant during the surgical implantation procedure may result in patient injury.
• Ensure that the appropriate size M6-L Artificial Lumbar Disc is chosen. Using an inappropriately sized M6-L Artificial Lumbar Disc may result in less than optimal clinical outcomes. Proper sizing should be determined in accordance with the M6-L Artificial Lumbar Disc Operative Technique Manual.

Cautions

• Perform a complete discectomy of the disc space by resecting the anterior annulus and removing the entire nucleus and cartilaginous endplates. Take care to preserve the lateral annulus and the bony endplates. The posterior annulus, PLL, and posterior osteophytes can be resected as needed.
• It is important to remove all anterior and posterior osteophytes on the superior and inferior vertebral endplates. Take care not to over-distract the disc space. Ensure proper alignment and placement of the device as misalignment may cause excessive wear and/or early failure of the device.
• Excessive removal of subchondral bone during the preparation of the vertebral endplates may lead to less than optimal clinical outcomes and is not recommended.
• Once removed from the package, keep the M6-L Artificial Lumbar Disc from coming into contact with any cloth, sponges or other foreign material that may become attached to the Titanium Plasma Spray Coating of the endplates.
• The M6-L Artificial Lumbar Disc is designed to be implanted with the inner endplates parallel to each other. Excessive endplate lordosis or kyphosis can lead to less than optimal M6-L Artificial Lumbar Disc performance.
• The selected M6-L Artificial Lumbar Disc angle should be within 3° of the index level disc angle.
• The M6-L Artificial Lumbar Disc cannot be re-positioned in an anterior direction without complete removal. Take care not to place the M6-L Artificial Lumbar Disc too posterior.
• Surgical implants must never be re-used or re-implanted. Even though the device appears undamaged, it may have small defects and internal stress patterns that may lead to early breakage.

Potential Adverse Effects

Below is a list of the potential adverse effects (e.g., complications) identified for: (1) those associated with any general surgical procedure, (2) those associated with anterior lumbar spine surgery, and (3) those associated with a lumbar artificial disc device, including the M6-L Artificial Lumbar Disc. In addition to the risks listed below, there is also the risk that surgery may not be effective in relieving symptoms, or may cause worsening of symptoms. Additional surgery may be required to correct some of the adverse effects.

General Surgery Risks

General surgical risks are, but may not be limited to:

• Infection/abscess/cyst, localized or systemic
• Blood mass/clots, including pulmonary emboli
• Medication and anesthesia reactions
• Phlebitis
• Pulmonary complications including atelectasis or pneumonia
• Soft tissue damage or fluid collections, including hematoma or seroma
• Abdominal or peritoneal adhesions or fibrosis
• Septicemia
• Wound dehiscence or necrosis
• Edema
• Pain/discomfort at the surgical incision and/or skin or muscle sensitivity over the incision which may result in skin breakdown, pain, and/or irritation
• Heart or vascular complications including bleeding, hemorrhage or vascular damage resulting in catastrophic or potentially fatal bleeding, ischemia, myocardial infarction, abnormal blood pressure, venous thromboembolism including deep vein thrombosis and pulmonary embolism, or thrombophlebitis
• Neurological complications including nerve damage, paralysis, seizures, changes to mental status, or reflex sympathetic dystrophy
• Complications of pregnancy including miscarriage or congenital defects
• Inability to resume activities of daily living
• Impairment of the gastrointestinal system including ileus or bowel obstruction
• Impairment of the genitourinary system including incontinence, bladder dysfunction, or reproductive system complications
• Hemorrhage possibly requiring a blood transfusion, with possible transfusion reaction
• Myocardial infarction
• Paralysis
• Poor tissue healing
• Cerebrovascular accident (CVA)
• Death

Anterior Lumbar Surgery Risks

Anterior lumbar surgical risks are, but may not be limited to:

• Infection/abscess/cyst, localized or systemic
• Injury or damage to nerves or blood vessels
• Paresis
• Soft tissue damage or fluid collections, including hematoma or seroma
• Spinal cord damage
• Dural tear with cerebrospinal fluid leakage
• Leg weakness or numbness
• Death
• Additional surgery
• Scarring, adhesions, or swelling including in the peritoneum
• Hernia
• Meningitis
• Back or leg pain
• Accumulation of fluid within the incision
• Bowel, bladder or sexual dysfunction
• Nerve root, cauda equina or spinal cord injury
• Abdominal or peritoneal adhesions or fibrosis
• Vertebral body fracture or other spinal fracture
• Dysesthesia or numbness
• Paresthesia
• Unresolved pain
• Surgical intervention at incorrect level
• Need for supplemental fixation
• Spinal instability
• Focal/Iatrogenic Scoliosis

Lumbar Artificial Disc Risks

Risks specific to Lumbar artificial discs, including the M6-L Artificial Lumbar Disc, are but may not be limited to:

• Infection/abscess/cyst, localized or systemic
• Allergic reaction to the implant materials
• Incompatibility with accessories
• Implant failure
• Device migration
• Device translation
• Device subsidence
• Early or late loosening of the device
• Device fatigue, fracture or breakage
• Device instability
• Separation of device components
• Placement difficulties, device malposition
• Improper device sizing
• Issues with the device instruments (e.g., bending or breakage) including the possibility that a fragment of a broken instrument may remain in the patient after implantation
• Excessive device height loss
• Wear debris (manifested as osteolysis and/or device damage/breakage/failure)
• Disc space collapse
• Material degradation (manifested as osteolysis and/or device damage/ breakage/failure)
• Placement difficulties requiring acute implant removal
• Excessive facet loading
• Kyphosis or hyper-extension
• Loss of flexibility
• Asymmetric range of motion
• Vertebral body fracture or other spinal fracture
• Spinal cord, nerve root, or cauda equina damage
• Development of spinal conditions, including but not limited to spinal stenosis, spondylolisthesis, or retrolisthesis
• Dural tear with cerebrospinal fluid leakage
• Soft tissue damage
• Nerve injury, paralysis or weakness that is temporary or permanent
• Injury or damage to nerves or blood vessels
• Epidural or retroperitoneal hematoma or excessive bleeding
• Dysesthesia or numbness
• Paresthesia
• Failure to relieve symptoms including unresolved pain
• Development of new pain
• Additional surgery due to loss of fixation, infection or injury
• Heterotopic ossification (Grades 1-4); Spontaneous fusion due to heterotopic ossification, development of bridging bone or osteophytes
• Periarticular calcification and/or fusion
• Removal, revision, reoperation or supplemental fixation of the disc
• Osteolysis, bone loss, or bone resorption
• Death
• Change in the alignment of the spine or loss of proper anatomic curvature, correction, height or reduction of the spine including spondylolisthesis, change in lordosis, or instability of the spine
• Focal/Iatrogenic Scoliosis

These conditions include all known or reasonably foreseeable adverse effects that may occur in relation to the use of the M6-L Artificial Lumbar Disc.

MRI Safety Information

Non-clinical testing has demonstrated that the M6-L Artificial Lumbar Disc is MR Conditional. A patient with the M6-L Artificial Lumbar Disc can be scanned safely in an MR system under the following conditions:

• Static magnetic field of 1.5-T or 3.0-T, 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 M6-L Artificial Lumbar Disc is expected to produce a maximum temperature rise of 2.6°C after 15-minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the M6-L Artificial Lumbar Disc extends approximately 10-mm from this device when imaged using a gradient echo pulse sequence and a 3.0-Tesla MR system.

How Supplied

• The M6-L Artificial Lumbar Disc is supplied sterile and is single use only. Do not re-sterilize or reuse the M6-L Artificial Lumbar Disc. Re-sterilizing and/or reusing the M6-L Artificial Lumbar Disc may result in impaired performance and could cause patient injury and/or the communication of infectious diseases between patients.

• Do not use the M6-L Artificial Lumbar Disc after the last day of the month of the “Use by date” on the label.

• Inspect the device package before opening. Do not use if package is damaged or shows any evidence of breached packaging, compromised device sterility, or storage above 60°C (140°F).
  The temperature recorder label on the box turns black if the product has reached 60°C (140°F).

• Use sterile technique to carefully remove the disc from the packaging. Inspect the M6-L Artificial Lumbar Disc to ensure it exhibits no signs of damage (e.g., metal and plastic damage).

• Once removed from the package, keep the M6-L Artificial Lumbar Disc from coming into contact with any cloth, sponges or other foreign material that may become attached to the Titanium Plasma Spray Coating of the endplates.

• The M6-L Artificial Lumbar Disc serial number and the size must be documented for each patient record.

Device Retrieval

Please contact Spinal Kinetics to receive specific instructions regarding the preferred method for explant handling and transport as well as data collection, including histopathological, mechanical, patient, and adverse event information. Please refer to M6-L Artificial Lumbar Disc Operative Technique Manual for step-by-step instructions on the required surgical technique for device removal. All explanted devices must be returned to Spinal Kinetics for analysis.
It is preferred that no cleaning, decontamination or sterilization be performed at the hospital. Some surgical centers may require that the device be decontaminated or sterilized prior to leaving the facility. Note that many sterilization methods will damage the device (e.g., autoclaving, immersion in alcohol), and the effects of other methods are unknown. Rinsing with water or saline is acceptable. If decontamination and sterilization are required, 10% neutral buffered formalin is best. If cleaning, decontamination or sterilization is performed, note what cleaning methods and materials were used.
It is preferred that the explanted device is packed “dry” (no fluid) or wrapped in formalin-soaked gauze. The device can be gently rinsed with water or saline to remove excess blood and fluids.
Send explant in a leak-proof container, with the date of removal, explanting surgeon, and any known information regarding initial implantation, reasons for removal, and adverse event information. Please note that the explanted M6-L Artificial Lumbar Disc should be removed as carefully as possible in order to keep the implant and surrounding tissue intact if possible. Also, please provide descriptive information about the gross appearance of the device in situ, as well as descriptions of the removal methods, i.e., intact or in pieces. Spinal Kinetics will request additional information regarding the reason for removal, patient information and associated clinical outcomes.
NOTE: All implant removals must be reported immediately to Spinal Kinetics.

References

• Orthofix - Medical Devices & Solutions
• Orthofix - Medical Devices & Solutions

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