The SPOTLIGHT® PL Access System is designed to aid surgeons in achieving minimally invasive posterolateral fusion, and will help drive multi-level and complex MIS cases.
The SPOTLIGHT PL 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.
POSSIBLE ADVERSE EFFECTS
Risks possibly associated with the use of the SPOTLIGHT PL 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 PL 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.
|Streamlined insertion technique without sequential dilation||Reduces steps and time for insertion, retraction, and removal|
|Integrated fiber optic lighting||Illuminates the fusion site allowing for direct visualization for multi-level MIS procedures|
Provides adaptability for complex MIS procedures
Allows for multi-level access and visibility for MIS fusion
|Expansion capabilities||Allows for up to 50 mm between distal blades; Intraoperative versatility and adaptability|
All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.