AmGraft^® product detail

Specifications IFU Catalogue v5.0

Properties (IFU): “AmGraft® is a biocompatible filler to supplement the dentoalveolar bone and provide structural function, by filling and/or augmenting bony voids or gaps in the dentoalveolar region.”

Indications for use IFU

AmGraft® is intended to be used to fill and/or augment bony voids or gaps in dentoalveolar surgery. It is recommended for the following clinical uses:

• Augmentation or reconstructive treatment of the alveolar ridge
• Filling of alveolar bone defects after root resection, apicoectomy, and cystectomy
• Filling of alveolar defects following dental extraction
• Filling of periodontal alveolar bone defects
• Filling of peri-implant alveolar bone defects

The five indications, one by one

Contraindication IFU

AmGraft® shall not be used in patients where general oral surgery is contraindicated (e.g. infection at the site of grafting).

Precautions IFU

• AmGraft® is restricted to use by a licensed clinician.
• AmGraft® is not intended to bear mechanical loads.
• A minimum period of 6 months’ healing is recommended at the augmented site using AmGraft®. The determination of the appropriate healing time has to be decided by the practitioner based on the diagnosis of the patient’s situation and condition.
• AmGraft® should be used with special caution in cases of all diseases or therapies which adversely affect the healing of the defect.

The diseases or therapies include but are not limited to:

• Acute and chronic infections at or surrounding the operating area (e.g. soft tissue infections; inflamed, bacterial bone diseases; osteomyelitis)
• Metabolic diseases, such as non- or poorly controlled diabetes mellitus, hyperparathyroidism, osteomalacia
• Disorders of calcium metabolism or treatment by pharmaceuticals interfering with calcium metabolism
• Treatment with steroids, antineoplastic drugs, immunosuppressives, high dose glucocorticoids
• Endocrinological bone diseases
• Severe renal dysfunction, severe liver disease
• Vascular impairment
• Autoimmune disease
• Radiotherapy
• Heavy smoking

Pregnancy, lactation and children IFU

Effect on pregnant or lactating women is not known. Effect on children is not known.

Warnings IFU

• AmGraft® is designed for use in one patient only. Do not re-use or re-sterilise.
• Do not use if the product label on the box or the outer packaging tray is missing or tampered with.
• Do not use if the box or the packaging seals are not intact.
• Do not use if the expiration date indicated on the label has passed.
• Care must be taken to prevent contamination. Do not use any contaminated product.
• The clinical outcome of mixing AmGraft® with other bone graft materials is not known.

Instructions for use IFU

• Follow the general principles of sterile handling and patient medication.
• AmGraft® must only be employed by or under the supervision of a licensed clinician with experience in the required surgical techniques and the use of biomaterials. The exact operating procedure depends on the location, type and size of the defect.
• To prepare the graft bed, carefully remove bone fragments, granulation and necrotic tissue before applying AmGraft®.

Application

1. Peel open the lid of the outer packaging tray using sterile techniques.
2. Transfer the sterile inner packaging tray into a sterile field, using sterile techniques.
3. Peel open the lid of the inner packaging tray.
4. Empty the desired amount of chips into a sterile dappen dish.
5. Place AmGraft® directly at the surgical site, or hydrate or mix the chips with the patient’s blood obtained from the surgical site or with saline to help carry the graft to the site.
6. Carry the chips to the site with a sterile spatula, curette or plastic carrier.
7. In situ modelling may be performed with a sterile spatula or other suitable instrument.
8. The mucoperiosteal flaps can be sutured to achieve primary closure and to minimise particle loss. In some cases the surgeon may want to place a surgical dressing or membrane over the wound.

Storage and sterilisation IFU

Keep AmGraft® in its original packaging, stored in a clean, dry place at room temperature, 10 °C to 30 °C. The expiration date is printed on the box and on the outer packaging tray. Do not use after the expiration date. Dispose of residuals as clinical waste.

AmGraft® is provided sterile in a sealed inner packaging tray and a sealed outer packaging tray. The contents of both trays are sterile and are enclosed in a non-sterile box. AmGraft® has been sterilised by ethylene oxide.

Adverse events IFU

The IFU (2022-06) states that reports on adverse events are not available at the present moment, and that adverse outcomes potentially attributable to the product must be promptly reported to Ventas Bio Pte Ltd or your distributor, and your country’s competent authority.

How to report an adverse event