Tedan UL-0360S-05 Mode D'emploi page 2

Product Description:
The TeDan Surgical Innovations, Inc. (TSI) Phantom UL ATP Sterile Screws are
single use, STERILE devices available in ten screw lengths (60, 80, 100, 120, 140,
160, 180, 200, 220, 240mm). They are supplied sterile, one (1) screw per pouch
and 5 pouches per box, and are intended for single use only.
REF#'s:
Product No.
UL-0360S-05
UL-0362S-05
UL-0364S-05
UL-0366S-05
UL-0368S-05
UL-0370S-05
UL-0372S-05
UL-0374S-05
UL-0376S-05
UL-0378S-05
The TSI Phantom UL ATP Sterile Screws are intended for the fixation of the blade
to the vertebral body to prohibit drifting in the Anterior to the Psoas approach
to the lumbar spine. Product is intended to be used by trained surgeons and is
designed for use with TSI Phantom Screwdrivers and Phantom UL Blade.
Surgical Setting:
Always ensure use of TSI instruments in a strictly sterile clinical environment.
Indication for Use:
Anterior to the Psoas surgery.
Intended Patients Groups:
Patients for which lumbar spine surgery from an anterior to the psoas approach
is required.
Intended User Groups:
Licensed practicing physicians who have been informed on the use of Phantom
ATP Sterile Screws used with TSI retractor systems. It is also expected that clinical
assistants are knowledgeable in setting up the retractor system.
Contraindications:
No known contraindications.
Intended Purpose:
The Phantom ATP Sterile Screws are used in combination with Phantom UL
Blades to fixate blades to the vertebral bodies. Products have been designed to
be used with Phantom UL Blades and TSI Screwdrivers.
Intended Clinical Benefits:
Provides a temporary anchoring mechanism for the blades during anterior to the
psoas lumbar spine surgery.
Instructions for use:
1. Inspect package prior to use and do not use if the package is damaged
or sterility has been compromised. If packaging has been damaged or
opened before use, DO NOT USE. Report any damaged packaging to TSI.
2. After selecting the desired length of retractor blade, choose the
corresponding screw. The length should be selected based upon blade
identification.
TSI-0102008
Screw Length (mm)
60
80
100
120
140
160
180
200
220
240
© 2022 TEDAN SURGICAL INNOVATIONS/ Rev01
Qty of Screws/Pouch
1
1
1
1
1
1
1
1
1
1
www.tedansurgical.com
Qty of Pouches/Box
5
5
5
5
5
5
5
5
5
5
ENGLISH
2