redefining the standard of care

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PHANTOM XL 3 LATERAL LUMBAR SURGICAL ACCESS SYSTEM Redefining the standard of care

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Page 1: Redefining the standard of care

PHANTOM XL3 LATERAL LUMBAR SURGICAL ACCESS SYSTEMRedefining the standard of care

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Mastering the ApproachPhantom XL3 Lateral Lumbar Surgical Access System

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Mastering the ApproachPhantom XL3 Lateral Lumbar Surgical Access System

PHANTOM XL3The Ultimate Surgical Access System

Efficient and safe access to the disc space is at the center of the surgical mission for the minimally invasive surgeon1. Yet, unencumbered access to the anatomy while maintaining a small surgical incision remains a clinical challenge.

The Phantom XL3TM Lateral Lumbar Surgical Access System from TeDan Surgical Innovations (TSI) transforms the lateral surgical retraction approach by eliminating instrumentation fiddle factor through the integration of unparalleled surgical access design elements -- all with the focus of elevating the surgeon’s armamentarium performance.

Equipped with UltraFix™ stabilization technology, boundless set-up versatility and effortless ease of use, the Phantom XL3 Lateral Lumbar Surgical Access System is poised to redefine the standard of care.

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Unwavering Stability

Reliable deployment of surgical instrumentation is a must to ensure that surgeon focus stays on what really matters. Even the slightest unintended shift may require tedious readjustments or encroachment of sensitive neural spinal anatomy.

UltraFix Stabilization Technology

Interlocking teeth on the starburst design enable rigid and precise fixation to the table mounted articulating arm, ensuring focused surgeon concentration by eliminating inadvertent movement. The table-mounted articulating arm features UltraFix stabilization technology, ensuring a reliable system for an uninterrupted surgeon experience.

Anchoring Shims

Engaging the intervertebral disc space or anchoring to the adjacent vertebral body, Phantom XL3 shims are specifically designed to eliminate frame migration ensuring streamlined access to the targeted disc space.

Phantom XL3’s top-loading locking mechanism secures retractor blades onto retractor frame ensuring efficient tissue retraction without unintended movement, especially during the implant trial and insertion phase of surgery.

Locking Blades

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Visualization Realized.

Surgical site exposure and visualization is paramount - after all, a surgeon cannot treat what is not visible.

Radiolucency

Phantom XL3 retractor blades are radiolucent providing superior visualization of end plate alignment, intervertebral disc space and other essential anatomical structures. Additionally, the ancillary 4th blade retractor is transparent during the imaging phase so that visualization is not impaired when anterior retraction is required.

Integrated Lighting

Integrated LED lighting deployed down blade channels deliver direct illumination to the surgical site limiting the need of a surgical headlight.

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B

Customizable Retraction

Each surgical procedure is as unique as its patient. A surgeon’s armamentarium should be adaptive to meet these diverse demands.

The articulating arm may be mounted onto one of two fixation points located on the retractor frame. Selecting the desired attachment location enables either posterior (A) or anterior retraction (B) by fixing a portion of the retractor and isolating the movement.

Adjustable Retraction Movement

Anterior Retraction

Once desired positioning is reached, retractor frame handles may be removed at the click of a button – creating an even lower-profile setup option.

Individual blade retraction enables patient specific exposure based on precise, incremental adjustments. The retractor frame is equipped with a 15° pivoting capability on each blade, providing additional exposure and minimizing muscle and tissue creep.

Blade Movement

15°

A

Posterior Retraction

Removable Handles

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(A) Caudal and Cephalic Blade Release Levers provide fast retraction adjustment.

(B) Button Releases for the caudal and cephalic blades allow users to quickly unlock blades during disassembly.

Universal blade channel design provides an area for shim deployment, enabling optimal visualization of the operative site.

Control at the Push of a Button

Improving Ease of Use

The Phantom XL3 Lateral Lumbar Surgical Access System eliminates the guesswork through its intuitive design and application-focused accessories. Eliminating fiddle factor was a top design priority for this next generation access system.

Hex driver tool enables controlled blade retraction and pivoting through enhanced tactile feedback.

A

B

4-Way RetractionThe XL3 Ancillary 4th Blade Cross Bar allows for the attachment of an optional 4th blade onto the retractor body allowing 4-way retraction.

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• A. Initial 8 mm dilator is radio-opaque to provide clear imaging during placement, while subsequent 13 and 18 mm dilators are radiolucent.

• B. Triangular stimulating electrodes at distal tip enable real time EMG monitoring. • C. Carefully selected outer dilator coating provides streamlined introduction into retro

peritoneal space.

With a uniquely-formulated outer dilator insulated coating, ultra-sensitive triangular stimulating electrodes and distinctly visible depth markings, the all-in-one Dilator Neuromonitoring Kit enables streamlined navigation of the retroperitoneal space and effortless blade selection. Safe and fast access to the lateral aspect of the disc has never been easier.

Improving Efficiency Through Design

Phantom Neuromonitoring Dilator Kit

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F. K-WiresAvailable in 1.5 mm sharp and blunt tips to initiate the dilation process and provide retractor placement guidance by locking into the disc space.

G. Neuromonitoring ProbeEnables pinpoint identification of neural anatomy anytime during the surgical procedure.

D. Dilator ClipCompatible with any 1.5 mm DIN safety connector enabling neuromonitoring capability when paired with insulated dilators.

E. Insulated DilatorsDelicately designed outer coating and ultra-sensitive triangular stimulating electrodes ensure consistent and safe navigation through the psoas and neural plexus.

Shims• H. 28 mm blunt spike shims enable a deeper intradiscal

anchor ensuring assembly stability in larger patients.• I. 20 mm spike shims are deployed into the disc space to

lock the retractor blade into desired location minimizing inadvertent movement.

• J. Screw shims engage with the vertebral body to provide solid anchoring adjacent to the disc space.

D

E

F

G

H I J J

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PHANTOM XL3 LATERAL LUMBAR SURGICAL ACCESS SYSTEMREDEFINING THE STANDARD OF CARE

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PHANTOM XL3 LATERAL LUMBAR SURGICAL ACCESS SYSTEMCAT. NO. PRODUCT CAT. DESCRIPTION QTY.

ML-0021 PHANTOM ML ROTATABLE TABLE CLAMP 1ML-0051 PHANTOM ML LED LIGHT SOURCE 1ML-0057 PHANTOM XL3 DILATOR HOLDER, RING HANDLED 1ML-0063 PHANTOM ML ANGLED ARTICULATING ARM, RACK CLAMP, LARGE 1ML-0902 PHANTOM XL3 ARM INTERFACE CONNECTOR FOR ML-0905 AND ML-0063 1ML-0068 PHANTOM XL3 LIGHT CABLE, SHIM TIP, 10’, NON-STERILE 1ML-0505 PHANTOM XL HEX DRIVER TOOL 2ML-0515 PHANTOM XL LATERAL SCREWDRIVER, LONG 1ML-0518 PHANTOM XL BLADE INTRODUCER GUIDE, 18 MM 1ML-0519 PHANTOM XL3 SHIM INSERTER TOOL 1ML-0905 PHANTOM XL3 3 BLADE RETRACTOR FRAME 1ML-0920 PHANTOM XL3 BLADE SET, 18 X 90 MM, PINK, ALUMINUM 1ML-0921 PHANTOM XL3 BLADE SET, 18 X 100 MM, BROWN, ALUMINUM 1ML-0922 PHANTOM XL3 BLADE SET, 18 X 110 MM, TEAL SPLASH, ALUMINUM 1ML-0923 PHANTOM XL3 BLADE SET, 18 X 120 MM, PURPLE SPLASH, ALUMINUM 1ML-0924 PHANTOM XL3 BLADE SET, 18 X 130 MM, GREEN, ALUMINUM 1ML-0925 PHANTOM XL3 BLADE SET, 18 X 140 MM, BLACK, ALUMINUM 1ML-0926 PHANTOM XL3 BLADE SET, 18 X 150 MM, BLUE, ALUMINUM 1ML-0927 PHANTOM XL3 BLADE SET, 18 X 160 MM, GRAY, ALUMINUM 1ML-0928 PHANTOM XL3 BLADE SET, 18 X 170 MM, BLACK SPLASH, ALUMINUM 1ML-0929 PHANTOM XL3 BLADE SET, 18 X 180 MM, BLUE SPLASH, ALUMINUM 1ML-0901 PHANTOM XL3 ANCILLARY 4TH BLADE CROSS BAR 1ML-0904 PHANTOM XL3 ANCILLARY 4TH BLADE RETRACTOR, 200 MM, ALUMINUM 1ML-0906 PHANTOM XL3 ANCILLARY 4TH BLADE RETRACTOR, 150 MM, ALUMINUM 1ML-0907 PHANTOM XL3 ANCILLARY 4TH BLADE RETRACTOR, 100 MM, ALUMINUM 1ML-0714 PHANTOM XL3 INSTRUMENT TRAY, ML-2014 1

SINGLE USE PRODUCTS

ML-0301 PHANTOM XL K-WIRE, BLUNT, 1.5 X 350 MM, SINGLE USE, 6/PACK, NON-STERILE 1ML-0303 PHANTOM XL K-WIRE, SHARP, 1.5 X 350 MM, SINGLE USE, 6/PACK, NON-STERILE 1ML-0342 PHANTOM XL PEDICLE SCREW PROBE, SINGLE USE, 10/BOX, STERILE 1ML-0345 PHANTOM XL DILATOR CLIP, SINGLE USE, 1/EACH, STERILE 1

ML-0441S PHANTOM XL INSULATED DILATOR, 8, 13, 18 MM, 3/SET, SINGLE USE, STERILE 1ML-0513 PHANTOM XL SPIKE SHIM, BLUNT, SINGLE USE, 60 MM, NON-STERILE, 28 MM 1ML-0514 PHANTOM XL SCREW SHIM, LONG, SINGLE USE, 28 MM, NON-STERILE 1ML-0516 PHANTOM XL SPIKE SHIM, SINGLE USE, 22 MM, NON-STERILE 1ML-0517 PHANTOM XL SCREW SHIM, SINGLE USE, 15 MM, NON-STERILE, 10 MM 1

OPTIONAL ITEMS

ML-0915 PHANTOM XL3 BLADE SET, 18 X 40 MM, RED, ALUMINUM 1ML-0916 PHANTOM XL3 BLADE SET, 18 X 50 MM, VIOLET, ALUMINUM 1ML-0917 PHANTOM XL3 BLADE SET, 18 X 60 MM, GOLD, ALUMINUM 1ML-0918 PHANTOM XL3 BLADE SET, 18 X 70 MM, YELLOW, ALUMINUM 1ML-0919 PHANTOM XL3 BLADE SET, 18 X 80 MM, TEAL, ALUMINUM 1 15

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TeDan Surgical Innovations, Inc.12615 W. Airport Blvd, Suite 200 Sugar Land, TX 77478Ph: 713-726-0886 • Fax: 713-726-0846 Toll Free: 877-726-0886www.tedansurgical.com [email protected]

LIT-0094, REV 1 ©TSI 2020

Phantom XL3 and UltraFix are trademarks of TeDan Surgical Innovations Inc.

References:1. Akbarnia A. et al. Extreme lateral interbody fusion-

XLIF. Current Orthopedic Practice, Volume 20, No. 3. May/June 2009.

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