Orthofix Firebird Wirbelsäulen-Fixationssystem Gebrauchsanleitung Seite 2

Orthofix Inc.
3451 Plano Parkway
Lewisville, Texas 75056-9453 U.S.A.
1-214-937-3199
1-888-298-5700
www.orthofix.com
Device System Name:
Firebird ® Spinal Fixation System
which includes:
Firebird ® System
Firebird ® Deformity System
®
Firebird NXG Spinal Fixation
System
Phoenix ® Minimally Invasive Spinal
Fixation System
®
Phoenix CDX™ Minimally Invasive
Spinal Fixation System
JANUS ® Midline Fixation Screw
JANUS ® Fenestrated Screw
Description:
The Firebird Spinal Fixation Systems include 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.
Indications for Use:
The Firebird Spinal Fixation Systems 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, and
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 Firebird Spinal Fixation Systems components are used with certain components of the Spinal
Fixation System (SFS), including rods, rod connectors and cross-connectors.
When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation
Systems 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 Systems are intended to be used with autograft or allograft.
The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation Systems is indicated
to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
For International Use Only
INSTRUCTIONS FOR USE
Important Information – Please Read Prior to Use
Australian Sponsor
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia
English
2
Medical Device Safety Service
(MDSS)
Schiffgraben 41
30175 Hannover
Germany
www.mdss.com
en
The JANUS Midline Fixation Screw and the JANUS Fenestrated Screw, when used with the Firebird
Spinal Fixation Systems is indicated to provide the surgeon with an open, minimally invasive or
midline approach for posterior spinal surgery.
The JANUS Fenestrated Screw with Cement when used in conjunction with Medtronic KYPHON®
HV-R Fenestrated Screw Cement, the JANUS Fenestrated Screws are intended to restore the
integrity of the spinal column even in the absence of fusion for a limited time period in patients
with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of
insufficient duration to permit achievement of fusion. The JANUS Fenestrated Screws augmented
with Medtronic KYPHON HV-R Fenestrated Screw Cement are for use at spinal levels where the
structural integrity of the spine is not severely compromised. The JANUS Fenestrated Screw with
Cement when used in conjunction with Medtronic KYPHON HV-R Fenestrated Screw Cement is
further indicated to include Diminished bone quality (i.e., osteoporosis, osteopenia, metastatic
disease).
Contraindications:
Contraindications include, but are not limited to:
1. Morbid obesity.
2. Mental Illness.
3. Alcoholism or drug abuse.
4. Pregnancy.
5. Metal, bone cement and Hydroxyapatite (HA) coating sensitivity/allergies.
6. Hydroxyapatite (HA) coated screws are not to be used with bone cement.
7. Severe osteopenia. (United States Use Only)
8. Patients unwilling or unable to follow post-operative care instructions.
9. 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.
10. Any circumstances not listed under the Indications for Use section.
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, bone cement, 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.
22. The JANUS Fenestrated Screw when used with KYPHON HV-R Fenestrated Screw Cement
may include adverse events of hemorrhage, hematoma, occlusion, seroma, edema,
hypertension, embolism, stroke, excessive bleeding, phlebitis, wound necrosis, wound
dehiscence, damage to blood vessels, or other types of cardiovascular system compromise.
23. The JANUS Fenestrated Screw when used with KYPHON HV-R Fenestrated Screw Cement
may include serious adverse events, some with fatal outcomes, associated with the
use of acrylic bone cements in the spine include myocardial infarction, cardiac arrest,
cerebrovascular accident, pulmonary embolism, and cardiac embolism. Although the
majority of these adverse events present early with the post-operative period, there have
been some reports of diagnoses beyond a year or more after the procedure.