Click Here For A PDF Of This Document

 
ENGLISH

OsseoGuard™
INSTRUCTIONS FOR USE

Intended Use:
OsseoGuard™ is a bioresorbable, implantable collagen material that is intended for use in periodontal and/or dental surgery procedures as a material for placement in the area of periodontal defects, dental implant, bone defect or ridge reconstruction to aid in wound healing post surgery.
Description:
OsseoGuard™ is a white, nonfriable membrane matrix engineered from highly purified type I collagen fibers derived from bovine Achilles tendon. OsseoGuard™ is resorbable which eliminates the need for a second surgical procedure that is normally required to remove a non-resorbable membrane.
OsseoGuard™ has a morphology of dense oriented fibers for mechanical strength. Macromolecular permeation studies have shown that the membrane is permeable to macromolecules. Its porosity is such that it effectively retards epithelial down growth and prevents gingiva connective cell migration into the wound site. The semipermeability properties of the membrane permit the exchange of essential nutrients for wound healing.
OsseoGuard™ is sterilized by gamma irradiation and is for single use only.
Administration:
OsseoGuard™ is packaged in a double sterile pouch. The outer pouch should be opened carefully, allowing the inner pouch to be placed onto a sterile field. The membrane should be removed from the inner pouch with sterile gloves or instruments.
The periodontal defect or bone defect is exposed by a mucoperiosteal flap and basic surgical procedures are performed (e.g. curettage). The clinician should perform thorough debridement and good planing of the defect. Space-making material such as autologous bone, demineralized bone matrix and ceramic materials may be used to fill the defect. As much tissue as possible should be preserved to allow for primary closure of the wound and correct positioning of the flaps. OsseoGuard™ can be placed either dry or hydrated. If the clinician prefers the handling characteristics of the hydrated collagen, the membrane can be hydrated in sterile water or saline solution for approximately five minutes prior to the final placement.
OsseoGuard™ can be trimmed to the size and shape of the defect in the dry or wet state using sharp, sterile scissors.
OsseoGuard™ should overlap the walls of the defect by at least 2 mm to allow complete bone contact and to prevent gingival connective tissue invasion below the material.
Fixation of the membrane may be indicated to avoid displacement due to loading or mobilization. The membrane can be sutured in place using absorbable sutures and a non-cutting needle. Resorbable tacks can also be used to affix the membrane. The mucoperiosteal flap is sutured over the collagen membrane and the wound should be closed completely to avoid accelerated resorption due to membrane exposure.
Post-operative Procedures:
OsseoGuard™ is completely resorbable and should not be removed. Patients should rinse with an antimicrobial agent such as chlorhexidine gluconate (Peridex) twice daily for four weeks following surgery. Beginning 24 hours after surgery, the wound site may be additionally swabbed with a cotton-tipped applicator dipped in the antimicrobial agent.
The patient should refrain from brushing the treated area for two weeks following the surgery. After this period, the patient may be instructed to gently brush the area with a soft toothbrush. Dental floss should not be used prior to four weeks following surgery. Coronal scaling and prophylaxis can be performed at follow-up visits, if indicated.
The patient should be seen seven to ten days following surgery for wound evaluation and removal of any closing sutures or periodontal packing. These follow-up visits should be repeated every two weeks thereafter, up to eight weeks following surgery. The patient may return to normal oral hygiene routine.
OsseoGuard™ should be completely resorbed 26 to 38 weeks following surgery. However, probing and subgingival scaling should not be performed prior to six months following surgery to prevent damage to immature tissues. Other assessments of clinical health may be repeated, including plaque, bleeding and tooth mobility indices.
Contraindications:
OsseoGuard™ is contraindicated in patients who have:
• acute infections or contaminated wound in the oral cavity
• known allergy to collagen of animal origin or other bovine-derived products
• clinically significant renal, hepatic, cardiac, endocrine, hematologic, autoimmune or systemic disease, which in the physician’s judgment, will prevent safe implantation or likely healing.
Warning:
Clinicians should use care in screening their patients for any known allergies to collagen or bovine-derived products. Hypersensitivity reactions have been noted with the use of other products containing bovine collagen; therefore, the possibility exists of developing a local sensitivity response to OsseoGuard™.
Precautions:
As with all surgical procedures, caution should be exercised when treating medically compromised patients such as patients receiving long-term steroidal therapy or currently taking anticoagulants. Patients with clinically significant systemic diseases, indicating a history of anaphylactic reactions, autoimmune diseases, uncontrolled diabetes or severe hypertension have not been implanted with the membrane; therefore, the safety and effectiveness for those patients have not been determined. Nor has it been evaluated in pregnant women, children and/or in patients with conditions involving extremely severe defects with little peridontium or bone.
OsseoGuard™ cannot be resterilized. Open, unused OsseoGuard™ must be discarded. 
Adverse Reactions:
Possible complications that can occur with any dental surgery include infection, swelling of the intraoral tissue, thermal sensitivity, gingival recession, excessive gingival bleeding, flap sloughing, resorption or ankylosis, with loss of crestal bone height, pain, or complications associated with the use of anesthesia. Minor discomfort may occur for a few days.
Safety:
The product is manufactured from bovine Achilles tendon, which is classified by European Standards as Class IV material (no detectable infectivity for Bovine Spongiform Encephalopathy, BSE). The bovine tendon is known to be one of the richest sources of type I collagen that is commercially available.
The manufacturing process for the product meets European Standards for animal tissue sourcing, handling and inactivation of Spongiform Encephalopathy (SE) pathogens. This process involves a treatment with sodium hydroxide that is a recognized method of inactivation of SE pathogens.
A viral inactivation study for the product’s manufacturing process was conducted by an independent laboratory. In this study three (3) manufacturing steps were evaluated for their ability to inactivate the following viral strains: Bovine Viral Diarrhea (enveloped virus) and Porcine Parvoviradae (non-enveloped virus). The study results showed that each of the three manufacturing steps, including the sodium hydroxide treatment, is effective in inactivating these viruses.
Storage:
The product should be stored at room temperature. Avoid excessive heat and humidity.
How Supplied:
One (1) membrane per package, size 1.5 cm x 2.0 cm, 2.0 cm x 3.0 cm, or 3.0 cm x 4.0 cm
Caution:
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician or dentist. Labeling Symbols:
Symbols may be used on some international package labeling for easy identification.

	Date of Manufacture		Use by date
	Catalogue number		By prescription only
	Batch code		Do not use if package  is damaged
	Sterlized using gamma irradiation		Do not re-use
	Caution, consult accompanying documents		Lower and Upper limit of temperature

EC Representative: MDSS GmbH Schiffgraben 41 D – 30175 Hannover, Germany	Manufactured by: Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, NJ 07417 USA Telephone: 201-405-1477 Fax: 201-405-1355
	Distributed by: BIOMET 3i, Inc. 4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454 Outside The U.S.: +1-561-776-6700 Fax: +1-561-776-1272