Customized instrumentation is needed to properly install the Triadyme cTDR, minimally including a Trial, Chisel, and Inserter. Each instrument is designed for implanting a particular size of device, and should not be used to implant other sizes.

Indications for Use

The Triadyme Cervical Total Disc Replacement is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy for intractable Symptomatic Cervical Disc Disease (SCDD). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a functional/neurological deficit with at least one of the following conditions confirmed by radiographic (CT, MRI, x-ray, etc.) studies: herniated nucleus pulposus, spondylosis (indicated by the presence of osteophytes), or loss of disc height. The Triadyme Cervical Total Disc Replacement is implanted via an open anterior approach. Patients receiving the Triadyme Cervical Total Disc Replacement should have failed at least six weeks of non-operative treatment for Symptomatic Cervical Disc Disease prior to implantation.

Contraindications

The Triadyme Cervical Disc Replacement should not be implanted in patients with the following conditions:

•ŸActive systemic infection or infection localized to the site of implantation

•Allergy or sensitivity to the implant materials (titanium or cobalt)

•Osteoporosis, defined as a DXA bone mineral density T-score equal to or less than -2.5

•Marked cervical instability on radiographs (e.g., radiographic signs of subluxation greater than 3.5 mm or angulation of the disc space more than 11 degrees greater than adjacent segments)

•Severe spondylosis characterized by bridging osteophytes or an absence of motion (less than 2 degrees)

•Significant cervical anatomical deformity or compromised vertebral bodies at the index level (e.g., ankylosing spondylitis, rheumatoid arthritis, or compromise due to current or past trauma)

•Significant kyphotic deformity or significant reversal of lordosis

Precautions

Patient selection is extremely important. In selecting patients for a total disc replacement, the following factors can be of extreme importance to the success of the procedure: the patient’s occupation, activity level, and general health, as well as the presence of senility, mental illness, alcoholism, or drug abuse. In addition, certain degenerative diseases (e.g., degenerative scoliosis or ankylosing spondylitis) may be so advanced at the time of implantation that the expected useful life of the device is substantially decreased. Medical conditions such as Alzheimer’s disease and emphysema may affect postoperative management.

In order to minimize the risk of periprosthetic vertebral fractures, surgeons must consider all co-morbidities, past and present medications, previous treatments, etc. Surgeons should screen patients to determine if a DXA bone mineral density measurement is necessary. If DXA is performed, the patient should not receive the Triadyme Cervical Disc (as noted in the contraindications above) if the DXA bone mineral density T-score is equal to or less than -2.5. It may be advisable, at the surgeon’s discretion, to exclude patients with a T-score less than -1.0.

The safety and effectiveness of this device has not been established in patients with the following conditions:

•Skeletal immaturity (less than 21 years of age) or advanced age (60 years or older)

•Axial neck pain as solitary symptom

•Neck or arm pain of unknown etiology

•More than one cervical level with DDD

•Facet joint disease or degeneration of involved vertebral bodies

•Prior surgery at the level to be treated

•Prior spinal fusion at an adjacent cervical level

•Clinically significant cervical instability

•Taking medication known to potentially interfere with bone or soft tissue healing (e.g., steroids)

•Less than six weeks of non-surgical treatment

•Extreme obesity, as defined by the NIH Clinical Guidelines Body Mass Index (a BMI of 40 or greater)

•Rheumatoid arthritis or other autoimmune disease

•Active malignancy

•Paget’s disease, osteomalacia, or other metabolic bone disease

•Chronic or acute renal failure or history of renal disease

•Unstable cardiac disease

•Severe, insulin-dependent diabetes

•Systemic disease, including AIDS, HIV or Hepatitis

•Pregnancy

Use aseptic technique when removing the Triadyme Cervical Disc from the innermost packaging. Also use care when handling the device to ensure that it does not come in contact with objects that could damage it. Damaged implants are no longer functionally reliable.

Take care to ensure that blood or other debris are not trapped between the bearing surfaces of the assembled device.

It has been reported in the literature that short-term postoperative use of non-steroidal anti-inflammatory drugs (NSAIDs) may reduce the instance of heterotopic ossification.

Implanted metal alloys release metallic ions into the body. The long term effects of these ions on the body are not known.

Surgical implants must never be re-used or re-implanted. Although the device may appear undamaged, it could have small defects and/or internal stress patterns that may lead to early breakage.

The components of Triadyme Cervical Disc should not be used with components or instruments of spinal systems from other manufacturers. See the surgical manual for step-by-step instructions.

Patients should be instructed in postoperative care procedures and should be advised of the importance of adhering to these procedures for successful treatment with the device. Patients should be advised against any activities that require repeated bending, lifting, and twisting, such as athletic activities. Gradual increases in physical activity will depend on individual patient progress and monitoring the device for stability and proper functioning.

Potential Adverse Events

Potential risks associated with the use of the Triadyme cTDR device include: 1) those commonly associated with any surgery; 2) those specifically associated with cervical spinal surgery using an anterior approach; and 3) those associated with a spinal implant, as well as those pertaining to the Triadyme cTDR. However, the causality of these adverse events is not exclusive to these categories.

There is also the risk that this surgical procedure will not be effective, and may not relieve or may cause worsening of preoperative symptoms.

1. Risks associated with any surgical procedure including: abscess; cellulitis; wound dehiscence; wound necrosis; edema; hematoma; heart and vascular complications; cerebrovascular complications including ischemia, stroke, hemorrhage, and thrombosis; hypertension; embolism; thromboembolism; thrombophlebitis; adverse reactions to anesthesia; gastrointestinal complications; pulmonary complications; organ, nerve, or muscular damage; seizure, convulsion, or changes to mental status; and complications of pregnancy including miscarriage and fetal birth defects.


2. Risks associated with anterior interbody surgery of the cervical spine include: dysphagia; dysphasia; dysphonia; hoarseness; vocal cord paralysis; laryngeal palsy; sore throat; recurring aspirations; nerve deficits or damage; tracheal, esophageal, and pharyngeal perforation; airway obstruction; external chylorrhea; warmth or tingling in the extremities; deficit or damage to the spinal cord, nerve roots, or nerves possibly resulting in paralysis or pain; dural tears or leaking;
   
   cerebrospinal fistula; discitis, arachnoiditis, and/or other types of inflammation; loss of disc height; loss of proper curvature, correction, height or reduction of the spine; vertebral slipping; scarring, herniation, or degeneration of adjacent discs; surrounding soft tissue damage, spinal stenosis; spondylolysis; otitis media; fistula; vascular damage and/or rupture; and headache.


3. Risks associated with implants in the spine, including the Triadyme cTDR device, are: early or late loosening of the components; disassembly; bending or breakage of any or all of the components; implant migration; malpositioning of implant;
   
   loss of purchase; sizing issues with components; anatomical or technical difficulties; implant fracture; bone fracture; skin penetration, irritation, pain, bursitis resulting from pressure on the skin from component parts in patients with inadequate tissue coverage over the implant; foreign body reaction to the implants including possible tumor formation, autoimmune disease, metallosis, and/or scarring; possible tissue reaction; bone resorption; bone formation that may reduce spinal motion or result in a fusion, either at the treated level or at adjacent levels; development of new radiculopathy; myelopathy or pain; cessation of bone growth of the operated portion of the spine; tissue or nerve damage caused by improper positioning and placement of implants or instruments; loss of neurological function; decreased strength of extremities; decreased reflexes; appearance of cord or nerve root injury; loss of bladder control or other types of urological system compromise; gastrointestinal system compromise including loss of bowel control; reproductive system compromise including erectile dysfunction, altered sensation, and loss of ability to achieve orgasm.


4. Loss and/or interference with radiographic and other imaging modalities because of the presence of the implant.


5. Wound, local, and/or systemic infections.


6. Surgical instrument bending or breakage, as well as the possibility of a fragment of a broken instrument remaining in the patient.


7. Inability to resume activities of normal daily living, including loss of consortium.


8. Death

How Supplied

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

•Do not use the Dymicron^TM Triadyme Cervical 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.

•Use sterile technique to carefully remove the disc from the packaging. Inspect the Triadyme Cervical Disc to ensure it exhibits no signs of damage.

•Once removed from the package, keep the Triadyme Cervical 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 backside.

•The Dymicron^TM Triadyme Cervical Disc serial number and size must be documented for each patient record.

  A Patient with this device can be scanned safely, immediately after placement under the following conditions:

•Static Magnetic field of 1.5-Tesla and 3-Tesla, only

•Maximum Spatial gradient magnetic field of 18,000-Gauss/cm (extrapolated) or less

•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

•Normal Operating Mode of Operation for the MR system