Fixation surgical screw long

Fixation Surgical Screw Long

Product Description

The Fixation Surgical Screw is a sterile (or non-sterile, as specified) implantable medical device intended for fixation in bone tissue. It is used in dental and surgical procedures to provide temporary or permanent stabilization of anatomical structures, devices, or prosthetic components.

The screw is designed to achieve mechanical retention in bone and may be available in various diameters, lengths, and thread designs to accommodate different clinical indications.

 Intended Use / Indications

The Fixation Surgical Screw is indicated for:

1. Stabilization and fixation in bone during surgical or dental procedures

2. Temporary anchorage in orthodontic or implant-related treatments

3. Securing membranes, plates, or other surgical components

4. Use in maxillofacial, oral, or general surgical applications

Target Patient Population

Adult patients or patients with adequate bone quality and quantity

Patients requiring bone fixation or temporary anchorage

Contraindications

Patients with systemic conditions that impair bone healing (e.g., uncontrolled diabetes, severe osteoporosis)

Active infection at the surgical site

Known hypersensitivity or allergy to device materials

Inadequate bone volume or density for stable fixation

Use outside intended anatomical locations

Precautions

Perform thorough pre-operative planning, including radiographic evaluation

Select appropriate screw dimensions based on bone anatomy

Use only compatible surgical instruments and drivers

Maintain strict aseptic conditions throughout the procedure

Avoid contact with non-sterile surfaces

Monitor insertion torque to prevent overloading

Follow accepted surgical protocols and guidelines

Possible Adverse Effects

Infection or inflammation at the surgical site

Pain, swelling, or discomfort

Screw loosening or migration

Damage to surrounding anatomical structures (nerves, vessels, roots)

Bone resorption or necrosis

Allergic reaction (rare)

Instructions for Use

Pre-Operative

1. Evaluate patient’s medical and dental history

2. Assess bone quality and quantity using appropriate imaging

3. Select correct screw type, diameter, and length

4. Ensure all instruments and devices are sterile

5. Intra-Operative

6. Prepare the surgical site according to standard protocols

7. If required, drill a pilot hole using appropriate drills and irrigation

8. Insert the fixation screw using a compatible driver

9. Apply controlled torque to achieve primary stability

10. Avoid excessive force to prevent bone or screw damage

11. Verify proper positioning and stability

Post-Operative

1. Monitor the site for healing and signs of complications

2. Provide patient with appropriate post-operative care instructions

3. Remove the screw if indicated (for temporary applications) using a compatible driver

Sterilization

Supplied sterile: Do not use if packaging is damaged or opened

Single-use devices must not be resterilized

Non-sterile products must be sterilized prior to use using validated methods:

Steam sterilization (autoclave): 121–134°C (250–273°F)

Follow applicable standards and regulations