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INSTRUCTIONS FOR USE
Important Information – Please Read Prior to Use
Device System Name:
TDX™ Posterior Dynamic
Stabilization System
Description:
The TDX Posterior Dynamic Stabilization System is a STERILE, single-use only motion preserving
dynamic rod component used in conjunction with an Orthofix posterior pedicle screw system that
allows a surgeon to build a spinal implant construct. The dynamic rod attaches to the vertebral
body by means of screws and hooks to the non-cervical spine and consists of a polyurethane
core secured in an implant-grade titanium housing.
Indications for Use:
When used in skeletally mature patients with the Orthofix Firebird™ Spinal Fixation System
family of posterior pedicle screw systems or the Orthofix Spinal Fixation System (SFS) posterior
pedicle screw system, the TDX Posterior Dynamic Stabilization System is intended to provide
immobilization and stabilization of non-cervical spinal segments as an adjunct to fusion in the
treatment of the following acute and chronic instabilities using autogenous graft only:
1. Degenerative spondylolisthesis with objective evidence of neurologic impairment.
2. Kyphosis.
3. Failed previous fusion (pseudoarthrosis).
The TDX Posterior Dynamic Stabilization System is to be installed in pairs with the single motion
segment at the same level and within a longer construct.
When used as part of a pedicle screw implant system, the TDX Posterior Dynamic Stabilization
System is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar – first sacral (L5-S1)
vertebral joint.
Please refer to the Firebird Spinal Fixation System or Spinal Fixation System (SFS) Instructions for
Use (IFU) for a complete list of Indications for Use.
Note:
For all indications, autogenous bone graft must be used.
Contraindications:
Contraindications include, but are not limited to:
1. Morbid obesity.
2. Mental Illness.
3. Alcoholism or drug abuse.
4. Pregnancy.
5. Metal sensitivity/allergies.
6. Severe osteopenia.
7. Patients unwilling or unable to follow post-operative care instructions.
8. If implanting the TDX Posterior Dynamic Stabilization System, any known allergy to
titanium, polyurethane, or ethylene oxide residuals.
9. Any circumstances not listed under the heading indications.
Potential Adverse Events:
All of the possible adverse events associated with spinal fusion surgery without instrumentation
are possible. With instrumentation, a listing of possible adverse events includes, but is not
limited to:
1. Device component fracture.
2. Loss of fixation.
3. Non-union.
4. Fracture of the vertebra.
5. Neurological injury.
6. Vascular or visceral injury.
7. Early or late loosening of any or all of the components.
8. Disassembly and/or bending of any or all components.
9. Foreign body (allergic) reaction to implants, debris, corrosion products, graft material,
including metallosis, straining, tumor formation, and/or auto-immune disease.
10. Pressure on the skin from component parts in patients with inadequate tissue coverage
over the implant possibly causing skin penetration, irritation, and/or pain.
11. Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
12. Infection.
13. Pain, discomfort, or abnormal sensations due to the presence of the device.
14. Hemorrhage.
15. Cessation of any potential growth of the operated portion of the spine.
16. Death.
Note:
Potential risks identified with the use of the device system may require additional surgery.
Warnings and Precautions:
1. The safety and effectiveness of pedicle screw systems have been established only for
spinal conditions with significant mechanical instability or deformity requiring fusion with
instrumentation. These conditions are: significant mechanical instability or deformity of
the thoracic, lumbar, and sacral spine secondary to degenerative spondylolisthesis with
objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis,
spinal tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of
these devices for any other condition are unknown.
2. The benefit of spinal fusions utilizing any pedicle screw fixation system has not been
adequately established in patients with stable spines.
3. Potential risks identified with the use of this device system, which may require additional
surgery, include: device component fracture, loss of fixation, nonunion, fracture of the
vertebra, neurological injury, and vascular or visceral injury.
4. Single use only. Reuse of devices labeled as single-use (e.g. implants, drills, tacks, trial
rods) could result in injury or reoperation due to breakage or infection.
5. The system instruments are sold non-sterile, and therefore must be sterilized before use.
6. The TDX dynamic rod is sold STERILE, and therefore should not be re-sterilized.
7. The system requires the use of autogenous bone graft.
8. Failure to achieve arthrodesis will result in eventual loosening and failure of the device
construct.
9. All implants are intended for SINGLE USE ONLY. Any used implant should be discarded.
Even though the device may appear undamaged, it may have small defects and internal
stress patterns that may lead to fatigue failure.
10. The implantation of the system should be performed only by experienced spinal surgeons
with specific training in the use of the dynamic rod as part of a pedicle screw spinal
system.
11. Physicians/Surgeons should consider the levels of implantation, patient weight, patient
activity level, other patient conditions, etc. which may impact the performance of the
system.
12. The safety and effectiveness of this device for the indication of spinal stabilization without
fusion have not been established.
13. The correct handling of the implant is extremely important. Implants should not be
excessively or repeatedly bent, notched or scratched. These operations can produce
defects in surface finish and internal stress concentrations, which may become the focal
point for eventual failure of the device.
MRI Compatibility Information:
The TDX Posterior Dynamic Stabilization System has not been evaluated for safety and
compatibility in the MR environment. It has not been tested for heating, migration, or image
artifact in the MR environment. The safety of TDX Posterior Dynamic Stabilization System in the
MR environment is unknown. Scanning a patient who has this device may result in patient injury.
Cleaning:
TDX Posterior Dynamic Stabilization System implants are provided STERILE. Do not use the
implant if the package is opened or damaged or if the expiration date has passed. Please discard
all open and unused implants. Do not re-sterilize an opened and unused implant.
All instruments must be thoroughly cleaned and sterilized after each use. Cleaning may be done
using validated hospital methods or following the validated cleaning processes described below.
None of the instruments require disassembly prior to cleaning.
From Point of Use:
Whenever possible, do not allow blood, debris or body fluids to dry on instruments. For best
results and to prolong the life of the surgical instrument reprocess immediately after use.
1. Remove excess body fluids and tissue from instruments with a disposable, non-shedding
wipe. Place instruments in a basin of purified water or in a tray covered with damp
towels. Do not allow saline, blood, body fluids, tissue, bone fragments or other organic
debris to dry on instruments prior to cleaning.
2. For optimal results, instruments should be cleaned within 30 minutes of use or after
removal from solution to minimize the potential for drying prior to cleaning.
3. Used instruments must be transported to the central supply in closed or covered
containers to prevent unnecessary contamination risk.
Note:
Soaking in proteolytic enzymatic detergents or other pre-cleaning solutions facilitates
cleaning, especially in instruments with complex features and hard-to-reach areas (e.g.
cannulated and tubular designs, etc.). These enzymatic detergents as well as enzymatic foam
Orthofix Inc.
3451 Plano Parkway
Lewisville, Texas 75056-9453 U.S.A.
1-214-937-3199
1-888-298-5700
www.orthofix.com
Medical Device Safety
Service (MDSS)
Schiffgraben 41
30175 Hannover
Germany
+49 511 6262 8630
www.mdss.com
Australian Sponsor
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia
