ORTHOFIX MS1077 Opus Strip Osteoconductive Scaffold Instruction Manual
- June 4, 2024
- ORTHOFIX
Table of Contents
Opus™ Strip
Osteoconductive Scaffold
INSTRUCTIONS FOR USE
DEVICE DESCRIPTION
Opus™ Strip is a collagen mineral composite matrix processed into strip form for surgical implantation. The principal components of Opus™ Strip are bovine type I collagen and an organic bovine bone mineral. The mineral particles are dispersed within collagen fibers forming a three-dimensional open porous matrix consisting of 80% bone mineral and 20% collagen. Opus™ Strip is provided as a sterile, dry material that is hydrated with autogenous bone marrow at the point of use. Opus™ Strip is fully resorbed during the natural process of bone formation and remodeling.
INDICATIONS
Opus™ Strip, combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone.
CONTRAINDICATIONS
Opus™ Strip must not be used in patients with osteomyelitis at the operative site. Opus™ Strip must not be used in patients with a history of anaphylaxis, history of multiple allergies, known allergies to bovine collagen, or who are being treating for desensitization to meat products because this product contains bovine collagen.
WARNINGS
Opus™ Strip should not be used in fractures of the growth plate, segmental defects, direct contact with the articular space, and open fractures.
PRECAUTIONS
Caution should be exercised when treating individuals with bleeding diatheses
of any etiology.Opus™ Strip should not be used to treat large defects that in
the surgeon’s opinion would fail to heal spontaneously. Opus™ Strip must be
used with internal or external fixation as indicated or required.
The use of Nonsteroidal Anti-inflammatory (NSAIDs) medications may delay graft
healing. The use of alternate means of pain control should be considered
whenever possible. Abstinence from smoking during and after treatment is
highly advised.
If there is any evidence of compromised sterility (e.g., torn packaging), the
device must not be used.
Opus™ Strip cannot be re-sterilized. Open, unused products must be discarded.
In vivo stability may be adversely affected if re-sterilized. Cross-
contamination and infection may occur if re-used.
ADVERT SE EFFECTS
The complications and inherent risks associated with bone grafting surgery are
not anticipated to increase with the use of Opus™ Strip. Potential
complications of surgery include wound infection, reaction to medications or
anesthesia, pain, thromboembolism, cardiac or pulmonary complications, and
blood loss. Potential postoperative risks include, but are not limited to a
hematoma, urinary retention, thrombophlebitis, and continued pain. Also, all
patients will be exposed to the same risks associated with any bone grafting
procedure such as fracture, migration, resorption or rejection of the graft,
delayed union, nonunion, or pseudarthrosis. These complications may require
regrafting or revision. In addition, in some instances Opus™ Strip may need to
be removed from the body, thus creating the need for a second surgery.
The possibility exists also for the failure of the implant due to incorrect
surgical technique, patient noncompliance during postoperative rehabilitation,
and other unforeseen problems. A small number of patients may experience
localized immunological reactions to this device that generally consist of
transient localized edema, swelling, and rash. Although there is no evidence
that the device will be unsafe or ineffective in such patients, the safety and
effectiveness of the device in these patients have not been established.
Opus™ Strip has not been used in clinical studies to treat patients with
metabolic bone disease, significant vascular disorders or clotting disorders,
uncontrolled diabetes, ankylosing spondylitis, achondroplasia, or in patients
undergoing anticoagulation therapy, immunosuppressive therapy, or steroid
therapy. No clinical data exist for use of Opus™ Strip in children or pregnant
women.
DIRECTIONS FOR USE
The procedure must be performed in an operating room under aseptic conditions. The patient should be anesthetized or sedated, as required. After adequately exposing the bone requiring grafting, the bones should be debrided until the healthy bleeding bone is exposed throughout the graft site.
- Determine the number of Opus™ Strip to be used based on the size or volume of the defect to be filled.
- Aspirate bone marrow to the matrix on an estimated 1:1 basis (e.g., use approximately 8-10 mL bone marrow for each Opus™ Strip).
- Transfer the aspirate immediately into a sterile bowl. Add a small amount of heparin (20 units of heparin/1mL marrow) to prevent the bone marrow aspirate from clotting.
- Hydrate each Opus™ Strip with bone marrow jus prior to implantation-NOTE: Hydration should require more than 1 minute.
- Gently pack the defect maintaining the structure of Opus™ Strip and the saturated bone marrow aspirate.
- If irrigation is used, it must be performed prior to placement of Opus™ Strip.
HOW SUPPLIED
Each unit of Opus™ Strip contains single or multiple strips (2 cm x 6.25 cm x 0.8 cm) and is approximately 10cc in volume. Opus™ Strip is provided in a sterile, double peel-pouch. Opus™ Strip is sterile, non-pyrogenic, and for one-time use only.
STORAGE
Store at room temperature (15°C°/59°F – 30°C/86°F). Do
not freeze or expose to extreme heat.
CAUTION
Federal (USA) law restricts this device to sale by or on the order of a physician.
PRODUCT COMPLAINTS
Any healthcare professional who has any complaints or is dissatisfied with
this product should notify Orthofix US
LLC, 3451 Plano Pkwy, Lewisville, TX 75056
Phone: 888-298-5700
Email: [email protected]
FURTHER INFORMATION
For product information, sales inquiries, customer service, or to obtain a surgical technique, please contact your sales representative or Orthofix US LLC Customer Service at Email: [email protected]
LABELING SYMBOLS
Symbols may be used on package labeling for easy identification.
| Use By Date
---|---
| Do Not Reuse
| Do not use if the product
sterilization barrier or its packaging is compromised
| Consult instructions for use
| Sterilized using irradiation
| Lot number
| Federal (USA) law restricts this device to sale by or on the order of a
physician or dentist
| Reference number
| Temperature Limitation
| Manufacturer
Manufacturer:
Collagen Matrix, Inc.
15 Thornton Road
Oakland, NJ 07436 USA
Distributed by:
Orthofix US LLC
3451 Plano Parkway
Lewisville, TX 75056 USA
© 2022 Orthofix US LLC. All rights reserved.
Documents / Resources
|
ORTHOFIX MS1077 Opus Strip Osteoconductive
Scaffold
[pdf] Instruction Manual
MS1077 Opus Strip Osteoconductive Scaffold, MS1077, Opus Strip Osteoconductive
Scaffold
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