Orthofix Firebird Instrucciones De Uso página 4

Patient Information:
The temporary internal fixation devices used in your recent spinal surgery are metallic implants
that attach to the bone and aid in the healing of bone grafts. These implants have been shown
to be valuable aids to surgeons in the treatment of bony fusions. These devices do not have
the capabilities of living bone. Intact living bone is self-repairing, flexible and occasionally
breaks and/or degrades. The anatomy of the human body places a size limitation on any
artificial fixation device used in surgery. The maximum size limitation increases the chances of
the mechanical complications of loosening, bending or breaking of the devices. Any of these
complications could result in the need for additional surgery. Accordingly, it is very important
that you follow the recommendations of your physician. Use braces as instructed. By following
these instructions, you can increase your chances of a successfully result and reduce your risk of
injury and/or additional surgery.
Packaging:
Packages for each of the components should be intact upon receipt. If a consignment system
is used, all sets should be carefully checked for completeness and all components should be
carefully checked for damage prior to use. Damaged packages or products should not be used
and should be returned to Orthofix.
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System instruments and
implants are provided in a modular case specifically intended to contain and organize the system
components. The system instruments are organized into trays within the modular case for easy
retrieval during surgery. These trays also provide protection to the system components during
shipping. Additionally, individual instruments and implants will be provided in sealed poly bags
with individual product labels attached to them.
Note: Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System HA coated screws
are provided sterile. Do not use if the package is opened or damaged, or if the expiration date
has passed.
Product Complaints:
Any Health Care Professional (e.g., customer or user of this system of products) who has any
complaints or who has experienced any dissatisfaction in the product quality, identity, durability,
reliability, safety, effectiveness and/or performance, should notify Orthofix Inc., 3451 Plano
Parkway, Lewisville, TX 75056, USA, by telephone at 1-214-937-3199 or 1-888-298-5700 or by
e-mail at complaints@orthofix.com.
Further Information:
Recommended operative techniques for the use of these systems are available upon request
from Orthofix at the phone numbers provided above.
Latex Information:
The implants, instruments and/or packaging material for the Firebird Spinal Fixation System and
Phoenix MIS Spinal Fixation are not formulated with and do not contain natural rubber. The term
"natural rubber" includes natural rubber latex, dry natural rubber, and synthetic latex or synthetic
rubber that contains natural rubber in its formulation.
Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
AW-44-9902 Rev.CG
FB-1804 © Orthofix, Inc. 8/2018
CAPA Symbols Chart revised2 - Firebird
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Federal (U.S.A.) law restricts this device to sale
by or on the order of a physician
See Instructions for Use
Use By Date
Orthofix.com/IFU
Manufacturer
Single Use Only Authorized
Representative
Do Not Reuse
Catalogue Number
Do Not Resterilize
Provided Non-Sterile
Serial Number
Sterilized Using
Lot Number
Irradiation