Orthofix Firebird Instrucciones De Uso página 2

Device System Name:
Firebird Spinal Fixation System
®
Phoenix Minimally Invasive
®
Spinal Fixation System
JANUS Midline Fixation Screw
®
Phoenix CDX™ Minimally Invasive
®
Spinal Fixation System
Firebird NXG Spinal Fixation System
®
Description:
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are temporary,
multiple component systems comprised of a variety of non-sterile and sterile single use
components made of titanium alloy or cobalt chrome alloy that allow the surgeon to build a spinal
implant construct. The systems are attached to the vertebral body and ilium by means of screw or
hook fixation to the non-cervical spine. The systems consist of an assortment of rods, multi-axial
and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks,
iliac connectors and sterile packed HA-coated bone screws. A subset of the systems' components
may be used in pediatric patients. These components consist of a variety of screws ranging
in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm. The systems'
implants are not compatible with components or metal from any other manufacturer's system.
Indications for Use:
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended to
provide immobilization and stabilization of spinal segments in skeletally mature patients as an
adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium) in the treatment of the following
acute and chronic instabilities or deformities:
1. Degenerative disc disease (defined as discogenic back pain with degeneration of the
disc confirmed by history and radiographic studies).
2. Spondylolisthesis.
3. Trauma (i.e., fracture or dislocation).
4. Spinal stenosis.
5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).
6. Tumor.
7. Pseudoarthrosis.
8. Failed previous fusion.
When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System
must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated
to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components are used
with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors
and cross-connectors.
When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation
System and Phoenix MIS Spinal Fixation System are indicated as an adjunct to fusion to treat
adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended to be
used with autograft or allograft.
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. Use of the Firebird offset connectors for fixation to the ilium is contraindicated when the
sacrum is absent or insufficient for implantation of pedicle screws at the S1 or S2 spinal level.
9. Any circumstances not listed under the heading indications.
INSTRUCTIONS FOR USE
Important Information – Please Read Prior to Use
Orthofix Inc.
3451 Plano Parkway
Lewisville, Texas 75056-9453 U.S.A.
1-214-937-3199
1-888-298-5700
www.orthofix.com
English
EN
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. Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions,
distorted anatomy).
2. Pedicle screw malpositioning, with or without neurological or vascular injury.
3. Proximal or distal junctional kyphosis.
4. Pancreatitis.
5. Pedicle screw failure, such as screw or rod bending, breakage, or loosening, may also
occur in pediatric patients, and pediatric patients may be at increased risk for device-
related injury because of their smaller stature.
6. Device component fracture.
7. Loss of fixation.
8. Non-union.
9. Fracture of the vertebra.
10. Neurological injury.
11. Vascular or visceral injury.
12. Early or late loosening of any or all of the components.
13. Disassembly and/or bending of any or all components.
14. Foreign body (allergic) reaction to implants, debris, corrosion products, and graft material,
including metallosis, straining, tumor formation, and/or auto-immune disease.
15. Pressure on the skin from component parts in patients with inadequate tissue coverage
over the implant possibly causing skin penetration, irritation, and/or pain.
16. Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
17. Infection.
18. Pain, discomfort, or abnormal sensations due to the presence of the device.
19. Hemorrhage.
20. Cessation of any potential growth of the operated portion of the spine.
21. 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 this device has not been established for use as part of a
growing rod construct. This device is only intended to be used when definitive fusion is
being performed at all instrumented levels.
2. The use of pedicle screw fixation in the pediatric population may present additional risks
when patients are of smaller stature and skeletally immature. Pediatric patients may have
smaller spinal structures (pedicle diameter or length) that may preclude the use of pedicle
screws or increase the risk of pedicle screw malpositioning and neurological or vascular
injury. Patients who are not skeletally mature undergoing spinal fusion procedures may
have reduced longitudinal spinal growth or may be at risk for rotational spinal deformities
(the "crankshaft phenomenon") due to continued differential growth of the anterior spine.
3. The implantation of pedicle screw spinal systems in pediatric patients should be
performed only by experienced spinal surgeons with specific training in the use of this
pedicle screw spinal system in pediatric patients because this is a technically demanding
procedure presenting a risk of serious injury to the patient.
4. Preoperative and operating procedures, including knowledge of surgical techniques, good
reduction, and proper selection of placement of the implants are important considerations
in the successful utilization of the system in pediatric patients.
5. The selection of the proper size, shape and design of the implant for each patient is crucial
to the safe use of this device in pediatric patients.
6. 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 severe spondylolisthesis (grades 3
and 4) of the L5-S1 vertebra, 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.
7. The benefit of spinal fusion utilizing any pedicle screw fixation system has not been
adequately established in patients with stable spines.
8. Potential risks identified with the use of this device system which may require additional
surgery include: device component fracture, loss of fixation, non-union, fracture of the
vertebra, neurological injury and vascular or visceral injury.
9. Single use only.
10. Non-sterile; the screws, hooks, rods, dominoes, lateral offsets, spacers, staples, washers,
locking nuts, cross connectors, and instruments are sold non-sterile and therefore must be
sterilized before use.
11. To facilitate fusion, a sufficient quantity of autologous bone or other appropriate material
should be used.
12. Failure to achieve arthrodesis will result in eventual loosening and failure of the device
construct.
2
0086
Medical Device Safety Service
(MDSS)
Schiffgraben 41
30175 Hannover
Germany
+49 511 6262 8630
www.mdss.com