These posterior cervical spinal systems form a robust and complete posterior cervico-thoracic system. Nex-Link Spinal Fixation System and Nex-Link OCT System feature a strong occipital fixation option and a full range of screw diameters and hooks compatible with a 4.0mm diameter rod.
The Zimmer Spine Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants.
Longitudinal members consist of 4.0 mm diameter rods manufactured from commercially pure titanium per ASTM F-67. Rods are affixed to the posterior cervicothoracic spine via anchors.
Anchors are comprised of hooks for use in the cervical and thoracic spine and screws for use in the thoracic spine. These implants are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F-136. Hooks are intended to anchor to the vertebral lamina and come in various throat depths. Screws are intended for fixation to the thoracic pedicles and are available in various diameters and lengths.
Anchors also consist of accompanying locking plugs, manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F-136, to secure the rod to the hooks and/or screws.
Transverse connectors, or “cross-links”, are available to mechanically link two rods together in a construct. These implants are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F-136. Cross-links are available in various lengths to accommodate varying rod spacing.
Rod to rod connectors are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F136, and are designed to link the 4.0mm Nex-Link titanium rod to an adjacent 4.0mm or 5.5mm titanium rod.
Polyaxial offset connectors are available to mechanically link polyaxial screws to rods within a construct. These implants are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F-136.
The Zimmer Spine, Inc. Nex-Link OCT Occipital Cervical Plating System components are temporary implants that are used to stabilize the spine (occiput-T3) during the development of a solid spinal fusion in patients with degenerative disease, trauma (including fractures), and tumor pathology.
The system consists of a modular plate, rod-to-plate connectors, hooks and pre-contoured rods. Cancellous and cortical bone screws are intended for fixation to the occiput and Cannulated Side-Loading Closed Screws are intended for fixation to the upper thoracic spine.
When intended to promote fusion of the cervical spine and the thoracic spine (C1-T3), the Nex-Link Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or tumors. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The polyaxial screws are not intended to be placed in the cervical spine. After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. The physician and the patient, taking into consideration the patient’s general medical condition and the potential risk to the patient of a second surgical procedure, must make any decision to remove the device.
The Nex-Link OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervicothoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto-axial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery, and tumors. The cancellous and cortical bone screws (3.5mm and 4.0mm diameters; 6.0mm-20mm threaded lengths) are used with the Nex-Link OCT System to allow for occipital fixation and limited to occipital fixation only. The Nex-Link OCT System 4.0mm cannulated side-loading closed screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spine for the indications specified above.
The Nex-Link System is not designed or sold for any use except as indicated. DO NOT USE THE NEX-LINK SYSTEM IMPLANTS IN THE PRESENCE OF ANY CONTRAINDICATION.
Contraindications include, but are not limited to:
The Nex-Link OCT Occipital Cervical Plating System is not designed or sold for any use except as indicated. DO NOT USE THE NEX-LINK OCT OCCIPITAL CERVICAL PLATING SYSTEM IMPLANTS IN THE PRESENCE OF ANY CONTRAINDICATION.
Contraindications include, but are not limited to:
Following are specific warnings, precautions, and possible adverse events, which should be understood by the surgeon and explained to the patients. These warnings do not include all possible adverse events, which can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to surgery.
a) Device component
b) Loss of fixation.
d) Fracture of the vertebra.
e) Neurological injury.
f) Vascular or visceral injury.
Re-operation to remove or replace implants may be required at any time due to medical reasons or device failure. If corrective action is not taken, complications may occur.
These complications may include but not be limited to:
Preoperative and operating procedures including knowledge of surgical techniques, good reduction, and proper selection and placement of the implant are important considerations in the successful utilization of the Nex-Link System by the surgeon.
Proper patient selection and the patient’s ability to comply with physician instructions and follow prescribed treatment regimen will greatly affect the results. It is important to screen patients and select optimal therapy given physical and/or mental activity requirements and/or limitations. If a surgical candidate exhibits any contraindication or is predisposed to any contraindication, DO NOT USE the Nex-Link System or the Nex-Link OCT System.
Patients who smoke have been shown to have an increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence. Patients with poor bone quality are also poor candidates for surgery.
Occurrence of any adverse events may require re-operation and removal of the implant. Adverse events may include, but are not limited to: