Indications
The MaxFuse® VBR System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The MaxFuse VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The MaxFuse VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The MaxFuse VBR System is intended for use with supplemental internal fixation systems cleared for the conditions listed above. The supplemental internal fixation systems that may be used include the Quantum® Spinal Fixation System, Streamline® TL Spinal Fixation System, and Streamline MIS Spinal Fixation System.
Warnings and Precautions
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other patient conditions may compromise the results. This device system is not intended to be the sole means of spinal support. The Pioneer Surgical MaxFuse VBR system must be used with additional anterior or posterior instrumentation to augment stability. Use of this product without a bone graft may not be successful. No spinal implant can withstand body loads without the support of bone. In this event where fusion does not take place, bending, loosening, disassembly and/or breakage of the device(s) may eventually occur.
Prior to surgery, consider preoperative and operating procedures, including knowledge of surgical techniques, proper selection and placement of the implant and good reduction. Only perform installation and positional adjustment of implants with special equipment and instruments specific to these devices. Do not use other instruments unless specifically recommended by Pioneer Surgical because other instruments may be incompatible.
Other warnings and precautions are as follows:
Warnings
One of the potential risks identified with this system is death. Other potential risks which may require additional surgery, include:
- Device and/or fixation component fracture
- Loss of fixation
- Non-union
- Fracture of the vertebrae
- Neurological injury
- Vascular or visceral injury
No implant system can withstand the forces of sudden dynamic loads such as falls or other accidents.
The components of this device are manufactured from a radiolucent polymer and include either Titanium (Ti) alloy or Tantalum (Ta) radiographic markers. Mixing of implant components with different materials is not recommended, for metallurgical, mechanical and functional reasons.
This system has not been evaluated for safety and compatibility in the MR environment. This system has not been tested for heating or migration in the MR environment.
Precautions
Only spine surgeons who have sufficient experience should carry out vertebral body replacement with the implant system. A thorough understanding of the technical principles, clinical applications and risks associated with vertebral body replacement is necessary before using. Contact Pioneer Customer Service if system specific training is desired.
Preoperative planning and patient anatomy should be considered when selecting implant size and supplemental internal fixation.
Vertebral body replacement devices (regardless of the indication for which they are designated) are designed to withstand both full load bearing and the loads associated with long-term use which could result from the presence of non-union or delayed union. To ensure load-bearing ability and the loads associated with long-term use, supplemental fixation is required with the use of this device. Please refer to the product specific insert for the supplemental internal fixation systems for additional information, (i.e., descriptions, indications, etc.).
While proper implant selection can help minimize risks, the size and shape of human bones present limitations on the size, shape, and strength of implants. Internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone.
These devices can break when subjected to the increased loading associated with delayed union or non-union. Typically, internal fixation devices are load-sharing devices which hold a fracture in alignment until healing occurs. If healing is delayed, or does not occur, an implant could eventually break due to fatigue. Based on the fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact on the performance of the system. Loads produced by weight bearing and activity levels will dictate the longevity of the implant. The patient should understand that stress on an implant could involve more than weight bearing. In the absence of solid bony union, patient weight alone, muscular forces associated with moving, or repeated stresses of apparent relatively small magnitude, can compromise the implant or impact the degree of success of the union. Patients should be fully informed of these risks prior to and following surgery.
Check packaging of sterile products. For product that is provided sterile, do not use if sterile package has been opened or damaged. If sterile package has been opened or damaged, return the product to Pioneer Surgical.
Correct handling of the implant is extremely important. Notches or scratches put in the implant during the course of surgery may also contribute to breakage. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. If a device is scratched, notched or altered, the device must be discarded. Surgical implants must never be reused. An explanted implant should never be re-implanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage.
After treatment of a vertebral body fracture and identification of the presence of fusion, only the supplemental fixation component of a vertebral body replacement system, and not the VBR should be removed.
Certain degenerative diseases or underlying physiological conditions such as diabetes or rheumatoid arthritis may alter the healing process, thereby increasing the risk of implant breakage.
Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery.
See product specific surgical technique manual and package insert for complete instructions and labeling limitations.
