MaxAn® Anterior Cervical Plate System

Description

The MaxAn Anterior Cervical Plate System is a plate and screw system composed of titanium alloy (Ti-6Al-4V ELI).  The system includes self-drilling bone screws, which are available in various diameters. The plates have an integral locking component that secures the bone screws into the plate. Various instruments are available to facilitate implantation of the device.

Indications

The MaxAn Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disease of the cervical spine (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2–T1.

Contraindications

The MaxAn Anterior Cervical Plate System is contraindicated in patients with spinal infection or inflammation; morbid obesity; mental illness, alcoholism or drug abuse; pregnancy; metal sensitivity/foreign body sensitivity; inadequate tissue coverage over the operative site; open wounds local to the operative area, or rapid joint disease, bone absorption, osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication since the condition may limit the degree of obtainable correction, the amount of mechanical fixation and/or intolerance.

Warnings

• This device is not approved for screw attachments to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
• Selection of Implants. Selection of proper size, shape and design of the implant increase the potential for success. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size and strength of implants.
• Implant strength and loading. These devices are not designed to withstand the unsupported stress of full weight bearing and/or load bearing, and cannot withstand activity levels and/or loads equal to those placed on normal healthy bones. If healing is delayed or does not occur, the implant could eventually break due to metal fatigue. Loads produced by weight bearing and activity levels will dictate the longevity of the implant.
• Corrosion. Contact of dissimilar metals (e.g., titanium and stainless steel) accelerates the corrosion process, which could enhance fatigue fracture of the implants. Therefore, only use like or compatible metals with implants that are in contact with each other.

Precautions

• Do not reuse. Do not reuse implants/devices. While an implant/device may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant/device. Do not treat patients with implants/devices that have been even momentarily placed in a different patient
• Handling of implants. Titanium implants are to be handled with care. If contouring of the plate is required, avoid sharp bends and reverse or repetitive bends. Avoid notching or scratching of the device, which could produce internal stresses and lead to early breakage. Avoid bending across the screw holes
• Implant removal after healing. After healing is complete, the implant may be removed since it is no longer necessary. Implants that are not removed may result in complications such as implant loosening, fracture, corrosion, migration, pain or stress shielding of bone, particularly in young, active patients. Implant removal should be followed by adequate postoperative management.
• Adequate patient instructions. A patient must be instructed on the limitations of the metallic implant, and should be cautioned regarding physical activity and weight bearing or load bearing prior to complete healing.
• Surgical techniques. The device is recommended for use by surgeons thoroughly familiar with the relative current literature, surgical techniques, implantation technique for this device, and postoperative care of the patient. 
• The surgeon must ensure that all necessary implants and instruments are on hand prior to surgery. The device must be handled and stored carefully, protected from damage, including from corrosive environments. They should be carefully unpacked and inspected for damage prior to use.
• All instruments must be cleaned and sterilized prior to surgery.
• Zimmer Biomet Spine implants should not be used with implants or instruments from another manufacturer for reasons of metallurgy, mechanics and design.
• Based on fatigue testing results, when using the MaxAn Anterior Cervical Plate System, the surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact the performance of this system.
• Non-clinical testing has demonstrated that the MaxAn plates are MR conditional. Patients with these plates may be scanned safely under the following conditions:

MRI Safety Information

Patients with the MaxAn Cervical Plate are not at added risk during MR imaging for scan sequence with a whole-body averaged SAR of less than 2 W/kg and in normal operating mode, as defined in IEC 60601-2-33. Edt. 3.1.

Non-clinical testing has demonstrated the MaxAn Cervical Plate is MR conditional. It can be scanned safely under the following conditions:

• Static magnetic field of 1.5 Tesla (T) or 3 Tesla (T)
• Spatial gradient field of 2500 Gauss/cm or less
• Quadrature transmit body coil
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of <2 W/kg (normal operating mode)
• Under the scan conditions defined above, the MaxAn Cervical Plate is expected to produce a maximum temperature rise of 9ºC after 15 minutes of continuous scanning. In image artifact tests performed in a GE Signa HDxt 3 T MR system according to ASTM F2119-07, the image artifact extended less than 10 mm from the implant for spin echo images and less than 22 mm for gradient images.