Instructions For Use - acumed Acu-Loc Instrucciones De Uso

US
Acu-Loc® and Acu-Loc® 2 Plating Systems
These instructions are intended for the Operating Surgeon and supporting Healthcare
US
Professionals. The US instructions are intended for users in the United States and its
territories.
DESCRIPTION
The Acumed Acu-Loc and Acu-Loc 2 bone plates, screws and accessories are designed to provide fixation
for fractures, fusions, and osteotomies.
INDICATIONS FOR USE
The Acumed Acu-Loc Plating System provides fixation for fractures, fusions, or osteotomies of the distal
radius and ulna. The Acumed Acu-Loc 2 Plating System provides fixation for fractures, fusions, or
osteotomies of the distal radius
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

U.S. English – US / PAGE 2
Rx only