Gibralt Cannulated Screw Operative Technique

Cannulated Screw
Operative Technique
spinE System
cannulated screw
renewing innovations.
enduring solutions.
Table of Contents
INTRODUCTION.................................................................................................................. 1
OPERATIVE TECHNIQUE OVERVIEW ............................................................................... 2
DETAILED OPERATIVE TECHNIQUE.................................................................................. 3
GUIDE WIRE INSERTION............................................................................................. 3
measure.................................................................................................................... 3
drill............................................................................................................................ 4
tap................................................................................................................................ 4
SCREW INSERTION..................................................................................................... 5
SCREW removal (if Necessary).......................................................................... 5
ImplaNT LISTING.............................................................................................................. 6
INSTRUMENT LISTING...................................................................................................... 7
INDICATIONS for use.............................................................................................. 9
CONTRAINDICATIONS................................................................................................ 9
warningS and precautions............................................................................... 9
2
INTRODUCTION
The Gibralt ® Spine System Cannulated Screw is
intended to provide posterior fixation as an aid
to fusion.
11
OPERATIVE TECHNIQUE OVERVIEW
1
2
Insert Guide Wire
Insert Cannulated Drill
3
4
5
Advancing the Drill
Reading the Measurement
5
6
Advancing the Tap
Insert Screw
2
DETAILED OPERATIVE TECHNIQUE
GUIDE WIRE INSERTION
Using the Guide Wire Driver, insert the pointed end
of the Threaded Guide Wire through the facet joint
to the desired depth as determined by fluoroscopy
(Figure 1).
measure
Place the Tissue Protector over the Guide Wire.
Then, insert the Cannulated Drill over the Guide
Wire and through the Tissue Protector until it
reaches the surface of the facet joint (Figure 2).
Once the Cannulated Drill is inserted, place the
Depth Gauge against the top of the guide wire.
The Depth Gauge will indicate in millimeters the
desired drill depth and screw length (Figure 3).
Figure 1
Inserting the Guide Wire
Figure 3
Reading the Measurement
Figure 2
Inserting the Cannulated Drilll
for Measurement
3
Figure 4
Attach Drill Bit Stop
Figure 5
Advancing the Drill
drill
Place the Drill Bit Stop over the drill so the cephalad
end aligns with the determined screw length. Slide
the locking ring down to lock at the indicated length
(Figure 4).
With the Tissue Protector and Guide Wire in place,
attach the Modular T or Straight Handle to the
Cannulated Drill and advance the Drill until the
Drill Bit Stop reaches the distal end of the tissue
protector (Figures 5 and 6).
tap
Place the Drill Bit Stop over the Cannulated Tap so
the cephalad end aligns with the determined screw
length. Slide the locking ring down to lock at the
indicated length.
Figure 6
Drill is fully inserted
4
With the Tissue Protector and Guide Wire in place,
attach the Modular T or Straight Handle to the
Cannulated Tap and advance the Tap through the
bone until the Drill Bit Stop reaches the distal end
of the tissue protector (Figures 7 and 8).
SCREW INSERTION
Choose the indicated screw diameter and length.
Attach the Modular T or Straight Handle to the
Cannulated Screw Driver, and insert the distal tip
of the Screw Driver into the head of the screw to
securely load the screw. Turn the handle clockwise
to insert the screw into the facet joint (Figure 9).
SCREW removal (if Necessary)
Using the cannulated screwdriver, insert the tip of
the screwdriver into the head of the screw. Turn
the screwdriver counter clockwise until the screw
has been completely removed from the bone
(Figure 10).
Figure 7
Advancing the Tap
Figure 8
Tap is Fully Inserted
Figure 9
Insert the Screw
Figure 10
Removing the Screw
5
ImplaNT LISTING
Catalog Number
Part Description
05-000-04-4028
05-000-04-4030
05-000-04-4032
05-000-04-4034
05-000-04-4036
05-000-04-4038
05-000-04-4040
05-000-04-4042
05-000-04-4044
05-000-04-4046
Cannulated – Double Lead Thread 4.0mm, 28mm L
Cannulated – Double Lead Thread 4.0mm, 30mm L
Cannulated – Double Lead Thread 4.0mm, 32mm L
Cannulated – Double Lead Thread 4.0mm, 34mm L
Cannulated – Double Lead Thread 4.0mm, 36mm L
Cannulated – Double Lead Thread 4.0mm, 38mm L
Cannulated – Double Lead Thread 4.0mm, 40mm L
Cannulated – Double Lead Thread 4.0mm, 42mm L
Cannulated – Double Lead Thread 4.0mm, 44mm L
Cannulated – Double Lead Thread 4.0mm, 46mm L
05-000-04-4528
05-000-04-4530
05-000-04-4532
05-000-04-4534
05-000-04-4536
05-000-04-4538
05-000-04-4540
05-000-04-4542
05-000-04-4544
05-000-04-4546
Cannulated – Double Lead Thread 4.5mm 28mm L
Cannulated – Double Lead Thread 4.5mm 30mm L
Cannulated – Double Lead Thread 4.5mm 32mm L
Cannulated – Double Lead Thread 4.5mm 34mm L
Cannulated – Double Lead Thread 4.5mm 36mm L
Cannulated – Double Lead Thread 4.5mm 38mm L
Cannulated – Double Lead Thread 4.5mm 40mm L
Cannulated – Double Lead Thread 4.5mm 42mm L
Cannulated – Double Lead Thread 4.5mm 44mm L
Cannulated – Double Lead Thread 4.5mm 46mm L
6
INSTRUMENT LISTING
Catalog Number
Part Description
05-009-17-0000
Guide Wire
05-009-45-0000
Drill Bit, 3.2mm, Cannulated, 20-50mm
05-009-46-0000
Tap, 4.0mm, Cannulated, 20-50mm
05-009-08-0000
Tap, 4.5mm, Cannulated, 20-50mm
05-009-52-0000
Tissue Guard
05-009-54-0000
Screwdriver Cannulated
7
Catalog Number
Part Description
200-7114
Wire Driver
05-009-74-0000
T-Handle Driver Ratcheting Cannulated Hudson
05-009-63-0000
Guide Wire Depth Gauge
05-009-75-0000
Straight Handle Driver Cannulated Hudson
05-009-37-0000
Bit Stop Adjuster/Lock
8
INDICATIONS for use
• Any case not needing a bone graft and fusion
The Gibralt Spine System Cannulated Screw is
indicated for the posterior surgical treatment at
C2-S1 (inclusive) spinal levels for the following: DDD
(neck pain of discogenic origin with degeneration
of the disc confirmed by history and radiographic
studies), spondylolisthesis, spondylolysis, fracture,
or failed previous fusion.
• Any case where the implant components selected
for use would be too large or too small to achieve
a successful result
• Any case that requires the mixing of metals from
two different components or systems
• Any patient having inadequate tissue coverage
over the operative site or inadequate bone stock
or quality
CONTRAINDICATIONS
Contraindications include, but are not limited to:
• Presence of overt infectious process or significant
risk of infection (immunocompromise)
• Any patient in which implant utilization would
interfere with anatomical structures or expected
physiological performance
• Signs of local inflammation
• Morbid obesity
• Presence of any neural or vascular deficit or other
compromising pathology, which may be further
injured by device intervention
• Pregnancy
• Any case not described in the indications
• Fever or leukocytosis
• Mental illness
warningS and precautions
• Grossly distorted anatomy caused by congenital
abnormalities
The Gibralt Spine System Cannulated Screw should
only be implanted by experienced spinal surgeons
with specific training in the use of this spinal
system because this is a technically demanding
procedure presenting a risk of serious injury to the
patient. In addition, the surgeon should consider
the levels of implantation, patient weight, patient
activity level, and other patient conditions (e.g.,
smoking, occupation), which may impact on the
performance of the system.
• Any other medical or surgical condition which
would preclude the potential benefit of spinal
implant surgery, such as the presence of congenital
abnormalities, elevation of sedimentation rate
unexplained by other diseases, elevation of white
blood count, or a marked left shift in the white
blood count differential count
• Suspected or documented metal allergy or
intolerance
The Gibralt Spine System Cannulated Screw has
not been evaluated for safety and compatibility
in the MR environment. The Gibralt Spine System
Cannulated Screw has not been tested for heating
or migration in the MR environment.
• Rapid joint disease, bone absorption, osteopenia,
osteomalacia and/or osteoporosis. Osteoporosis
orosteopenia is a relative contraindication since
this condition may limit the degree of obtainable
correction, stabilization, and/or the amount of
mechanical fixation
• Any patient unwilling to follow postoperative
instructions
9
Exactech is proud to have offices and distributors around the globe.
For more information about Exactech products available in your country, please visit www.exac.com
For additional device information, refer to the Exactech Spine–Instructions for Use for a device description, indications, contraindications, precautions and warnings. • For
further product information, please contact Customer Service, Exactech, Inc., 2320 NW 66th Court, Gainesville, Florida 32653-1630, USA. (352) 377-1140, (800) 392-2832
or FAX (352) 378-2617.
Exactech, as the manufacturer of this device, does not practice medicine, and is not responsible for recommending the appropriate surgical technique for use on a particular
patient. These guidelines are intended to be solely informational and each surgeon must evaluate the appropriateness of these guidelines based on his or her personal medical
training and experience. Prior to use of this system, the surgeon should refer to the product package insert for comprehensive warnings, precautions, indications for use,
contraindications and adverse effects.
The products discussed herein may be available under different trademarks in different countries. All copyrights, and pending and registered trademarks, are property of
Exactech, Inc. This material is intended for the sole use and benefit of the Exactech sales force and physicians. It should not be redistributed, duplicated or disclosed without the
express written consent of Exactech, Inc. ©2011 Exactech, Inc.
352-377-1140
1-800-EXACTECH
www.exac.com
716-13-31
Gibralt Op. Tech. 1211
*+$716-13-3102*