Instructions For Use - acumed Dual-Trak Mode D'emploi

EN
Dual-Trak Fixation Screw Systems
These instructions are intended for the Operating Surgeon and supporting Healthcare
EN
Professionals. The EN instructions are intended for users in English speaking countries outside
the United States and its territories.
DESCRIPTION
The Acumed fixation devices are designed to provide fixation of various fractures and osteotomies while
they heal.
INDICATIONS FOR USE
The Dual-Trak Clavicle Screw is intended for fusion and fixation of the clavicle.
CONTRAINDICATIONS
• Active or latent infection
• Sepsis
• Insufficient quantity or quality of bone, osteoporosis
• Soft tissue or material sensitivity
• Patients who are unwilling or incapable of following post-operative care instructions
These devices are not intended for screw attachment or fixation to the posterior elements (pedicles) of the
cervical, thoracic, or lumbar spine.
WARNINGS & PRECAUTIONS
Warning:
• The treatment or implant may fail, including sudden failure, as a result of:
- Loose fixation and/or loosening
- Stress, include stress from inappropriate bending of the implant during surgery
- Stress concentrations
- Stress of weight bearing, load bearing, or excessive activity
• Failure is more likely if the implant experiences increased loads due to delayed union, nonunion, or
incomplete healing. Failure is more likely if the patient does not follow post-operative care instructions.
• Nerve or soft tissue damage may result from surgical trauma or the presence of an implant.
• Instrument breakage or damage, as well as tissue damage, may occur when an instrument is subjected
to excessive loads, excessive speeds, dense bone, improper use or unintended use.
• Implants may cause distortion and/or block the view of anatomic structures on radiographic images.

Instructions for use

English (non-U.S.) – EN / PAGE 44