The SPOTLIGHT® Access System was developed to provide surgeons with a complete package for minimally invasive access to the spine. The system consists of ports with integrated lighting for enhanced intraoperative visualization, a rigid arm that allows adjustments to be made within the sterile field, and a comprehensive microdiscectomy instrument set.
The SPOTLIGHT Access System is intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port or retractor, down to the posterior and posterolateral bony spinal elements. These ports and retractors provide access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated.
Clinical and/or radiographic determinations that exclude the use of the SPOTLIGHT Access System include:
POSSIBLE ADVERSE EFFECTS
Risks possibly associated with the use of the SPOTLIGHT Access System are similar to those associated with any surgery to the planned area of instrument use. The most frequently stated risks are bleeding, damage to the surrounding soft tissue and infection. Each of these risks has also been used to describe the risks associated with conventional surgical intervention. Additional risks associated with the use of the SPOTLIGHT Access System, other than those described for surgery in general, may be instrument malfunction, such as bending, fragmentation, loosening and/or breakage (whole or partial). Breakage in the patient may increase surgical time since this instrument should not be implanted. Also, surgery may not be effective. Similar risks are associated with the system use in any part of the body.
Additional risks are attendant to surgery and the use of anesthesia, etc., and are not directly related to the use of the retractor. These include, but are not limited to:
WARNINGS AND PRECAUTIONS
WARNING: This product has labeling limitations. See package insert for additional warnings, precautions and possible adverse effects.
CAUTION: USA law restricts this device to sale by or on the order of physician.
|360 degrees of illumination||Eliminates intraoperative shadows and increased visibility|
|Integrated light source||May be used as an enhancement to, or a replacement for surgical microscope lighting|
|Wide range of port options||
Offers a variety of posterior MIS procedures (five port diameters: 12mm, 15mm, 18mm, 21mm, and 24mm with port lengths ranging from 30mm to 140mm in 10-mm increments)
Accommodates surgeon preference and patient anatomy
|Comprehensive instrument set bayoneted and optimized for MIS||Allows for a wide range of procedures|