Contraindications, potential complications, warnings and precautions:
In any surgical procedure, the potential for complications and adverse reactions exists. Contraindications include cases of inflammation, cases of active or suspected sepsis / infection and osteomyelitis and patients with certain metabolic diseases.
The risks and complications with these implants can include loosening, deformation or failure of the implant, acute post-operative wound infections and late infections with possible sepsis, thrombosis and embolism, wound hematoma and delayed wound healing, temporary and protracted functional neurological perturbation and tissue reactions as the result of allergy or foreign body reaction to dislodged particles.
All complications listed here are not typical of GriplastyTM but are in principle observed with any implant. Your surgeon will explain potential risks and complications associated with surgery, and give you instructions on the use and limitations of GriplastyTM.
Warnings and precautions related to the use of GriplastyTM include; Re-operation to remove or replace implants may be required at any time due to medical reasons or device failure. If appropriate action is not taken, complications may occur; Use of an undersized anchor in areas of high functional stresses may lead to implant fracture and failure; Postoperatively, until healing is complete, the fixation provided by this device should be protected. The postoperative regimen prescribed by the surgeon should be strictly followed to avoid adverse stresses being applied to the implant; Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the implant, are important considerations in the successful utilization of this device;
These devices have not been evaluated for safety and compatibility in the MR environment.
Product availability may not extend to all markets, as it is contingent upon regulatory and medical practices within each region. For inquiries concerning the accessibility of Field Orthopaedics products in your location, please reach out to your Field Orthopaedics representative or distributor.