TiMesh 

Indications

The TiMesh system is intended for use in any oral-maxillo-cranio-facial surgical reconstructive procedure, either orthognathic or trauma, wherein rigid or semi-rigid internal fixation is utilized to hold bone fragments together. Alternatively, the TiMesh system is indicated for use in reinforcing weak bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, and cement restriction. This product is not intended for spinal use.

CAUTION: THIS PRODUCT IS NOT INTENDED TO BE THE SOLE MEANS OF SUPPORT. NO SUCH IMPLANT CAN WITHSTAND BODY LOADS WITHOUT THE SUPPORT OF BONE. IN THIS EVENT, BENDING, LOOSENING, DISASSEMBLY, AND/OR BREAKAGE OF THE IMPLANTS WILL EVENTUALLY OCCUR.

Contraindications

Contraindications include, but are not limited to, the following:

• Active infections.
• Foreign body sensitivity. Where material sensitivity is suspected appropriate tests should made to rule out this possibility prior to implantation.
• Conditions which tend to limit the patient’s ability and/or willingness to cooperate and to follow instructions during the healing period.
• Any degenerative disease, the progress of which would adversely affect the placement of an implant.
• Insufficient quantity or quality of bone to securely anchor the implant.
• Blood supply limitations, radiation therapy, and/or previous infections which may tend to retard healing and increase the possibility of infection and/or rejection of the implant.

Warnings and Precautions

The physician is responsible for describing and explaining the following warnings, precautions and complications to the patient and/or his representatives prior to proceeding with any surgical procedures.

• Lint, fingerprints, talc and other surface contaminants or residues from latex gloves can cause foreign body or allergic reactions.
• Care must be taken to ensure that particulate contaminants are not introduced onto components during implantation or handling. This could result in improper performance of the system.
• To preserve the proprietary surface finish, these implants should be handled with clean instruments dedicated to titanium, or a talc-free gloved hand.
• An implanted device should never be re-used.
• Leftover implants which have been contaminated with blood or body fluids should be discarded per hospital procedure.
• Until bone healing is complete, the fixation provided by this system should be considered temporary and may not withstand extraordinary unsupported stresses.
• Detailed instructions on the use, limitations, and possible complications of the system should be given to the patient.
• Any decision to remove the system should take into consideration the potential risk to the patient of a second surgical procedure.
• Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the implants, are important considerations in the successful utilization of this system.
• Radiation therapy has been shown to decrease the chance of a successful result.
• Postoperatively as a precaution, before patients with implants receive any further surgery (such as dental procedures) prophylactic antibiotics may be considered, especially for high risk patients.

Complications

All of the complications associated with surgery are possible. Complications associated with implants may, in addition, include the following:

• Early or late loosening of any or all of the components.
• Disassembly, bending, and/or breakage of any or all of the components.
• Foreign body (allergic) reaction to implants, debris, corrosion products, possibly causing metallosis, staining, tumor formation, and/or autoimmune disease.
• Pressure from component parts on the skin and/or mucosa possibly causing penetration, perforation, dehiscence, irritation and/or pain. Bursitis. Tissue damage caused by improper positioning and placement of implants or instruments.
• Postoperative change in position, loss of correction, height, and/ or reduction.
• Infection.
• Loss of neurological function, including paralysis (complete or incomplete), dysesthesias, hyperesthesia, anesthesia, paraesthesia, and/or the development or continuation of pain, numbness, neuroma, or tingling sensation.
• Neuropathy, neurological deficits (transient or permanent).
• Scar formation, possibly causing neurological compromise around nerves, pain, skin blemishes, or discoloration.
• Fracture, microfracture, resorption, damage, migration, or penetration of any bone and/or bone graft or any bone graft harvest site at, above, and/or below the level of surgery.
• Non-union (or pseudarthrosis), delayed union, or mal-union.
• Cessation of any potential growth of the operated portion of the anatomy. Loss of mobility or function.
• Bone loss or decrease in bone density, possibly caused by stress shielding.
• Graft donor site complications including pain, fracture, or wound healing problems.
• Hemorrhage, hematoma, seroma, embolism, stroke, excessive bleeding, phlebitis, wound necrosis, wound dehiscence, or damage to blood vessels.
• Gastrointestinal and/or reproductive system compromise, including loss of consortium.
• Opthalmological compromise, including diploplia, blindness, and visual deficits.
• Impaired masticatory function.
• Development of respiratory problems, e.g., pulmonary embolism, bronchitis, pneumonia, etc.
• Change in mental status.
• Death.

Note: Additional surgery may be necessary to correct some of these complications.