The SImmetry Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruption and degenerative sacroiliitis.
Customary general contraindications associated with elective surgery should be observed. These include, but are not limited to: pregnancy; sensitivity or allergy to titanium; metabolic bone disease; clotting disorders; current treatment with therapeutic agents that may have an effect on the surgical site, surrounding tissue, or normal healing responses (e.g., chemotherapy, radiation therapy, chronic steroid treatment, anticoagulant therapy, kidney dialysis); or other metabolic or physical disorders that interfere with bone growth, bone maintenance, or wound healing.
Certain degenerative diseases or underlying physiological conditions may alter the healing process or prevent fusion, such as uncontrolled diabetes, active systemic infection, infection localized to the site of the proposed implantation, rheumatoid arthritis, or osteoporosis.
IMPORTANT CONSIDERATIONS ON IMPLANT USAGE
Be aware that there are specific warnings, precautions, and possible adverse effects that must be understood by the surgeon and explained to the patient.
The Warnings, Precautions and Potential Adverse Effects information below is a summary of these events and is not all encompassing. For a complete list of Warnings, Precautions, and Potentail Adverse Effects consult the SImmetry Instructions for use (link provided below) or speak with your physician.
MRI Safety. The SImmetry Sacroiliac Joint Fusion System has not been evaluated for safety and compatibility in the MR environment. The SImmetry Sacroiliac Joint Fusion System has not been tested for heating, migration or image artifacts at or near the implant site.
Surgeons and patients should be aware that in some cases surgical implants may loosen, bend, or break even if solid bony fusion occurs.
POTENTIAL ADVERSE EFFECTS
- Nonunion or delayed union
- Bending or fracture of implant
- Screw back out, bone stripping, possibly leading to implant loosening, migration, and/or reoperation
- Fracture of bony structures
- Decrease in peri-implant bone density, necrosis of bone, or bone loss
- Metal sensitivity, or allergic reaction to a foreign body
- Infection, early or late
- Pain, discomfort, or abnormal sensations due to the presence of the implant
- Iatrogenic vessel and/or nerve damage