Warnings
+ Surgery is not always successful. Preoperative symptoms may not be relieved or may worsen. Surgical knowledge of the procedure and the device are important, as is patient selection. Patient compliance is also important. Tobacco and or alcohol abuse may lead to unsuccessful results.
+ Implants are single use only and should not be reused. Once a device has been implanted, it must never be reused. Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents.
+ Appropriate endplate preparation and device selection is needed to obtain proper fit.
+ Delayed healing can lead to fracture of the implants due to increased stress and material fatigue. Patients must be fully informed of all the risks associated with the implant and the importance of following postoperative instructions regarding weight bearing and activity levels to facilitate proper bone healing.
+ The implant must be handled carefully, following the manufacturer’s instructions, to prevent damage to the implant.
+ Implants must not be modified or otherwise processed in any way.
+ Care must be taken to avoid using dissimilar metals, in contact with one another, as corrosion may occur. Additional fixation instrumentation that is used to stabilize the affected level must be made of compatible materials, such as Titanium or Titanium alloy. Corrosion may accelerate metal fatigue and lead to failure of the implant.
+ This surgical procedure requires the use of the screw fixation provided to stabilize the fusion site.

Precautions
+ The implantation of an 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.
+ Based on the fatigue testing results, the physician/surgeon should consider the level of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact on the performance of the system.
+ The surgeon must have a thorough knowledge of the mechanical and material limitations of surgical implants made of Titanium Alloy and be thoroughly familiar with the surgical technique for implanting the SureMAX®-SA Cervical Standalone System for the given Indications for Use.
+ The surgeon should be familiar with the various devices and instruments and verify that all are available before beginning the surgery. Additionally, the packaging and implant should be inspected for damage prior to implantation.
+ In the event that removal of the implant is considered (e.g. due to loosening, fracture, migration of the implant; infection; increased pain, etc.), the risks versus benefits must be carefully weighed. Such events can occur even after healing, especially in more active patients. Appropriate postoperative care must be given following implant removal to avoid further complication.
+ Implants must be fully seated within the inserter prior to use. Care must be taken not to over-tighten the implant-inserter assembly. Additionally, care must be taken not to manipulate the inserter implant interface in a way not recommended by the surgical technique.
+ The surgeon must ensure that the implant is properly seated prior to closing of the soft tissue.
+ Extreme caution must be used around the spinal cord, nerve roots and blood vessels.

MRI Safety Information
The SureMAX®-SA Standalone System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of these implants in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.