Craniofit® Customized PEEK plates
Craniofit® Customized PEEK plates
Precise Customization for a Range of Complex Anatomies
CRANIOFIT® Customized PEEK Plates are designed to address a range of complex cranial deformities. They are manufactured using a clinically-proven, bioengineered material for strength, comfort, and durability. Their lightweight and personalized design has the potential to improve facial symmetry and patient satisfaction while reducing complications.1,2,3
Frequently Asked Questions
1 He Z, et al. A Perioperative Paradigm of Cranioplasty With Polyetheretherketone: Comprehensive Management for Preventing Postoperative Complications. Front. Surg. 9:856743
2 Lethaus B., et al. Patient-Specific Implants Compared with Stored Bone Grafts for Patients with Interval Cranioplasty. J Craniofac Surg 2014;25:206Y209
3 Zhang Q., et al. A Large Multicenter Retrospective Research on Embedded Cranioplasty and Covered Cranioplasty. World Neurosurg 2018 Apr;112:e645-651.
Indications: The PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) is intended to replace bony voids in the cranial and /or craniofacial skeleton, excluding maxillofacial and /or oral regions.
- Patients associated with serious systemic infection or systemic disease, such as serious diseases of heart, lungs, liver, kidney, hematopoietic systems and so on;
- Due to physical or psychological reason, the patient doesn’t want to or can’t follow the doctor’s instructions for recovery;
- Patients with foreign body allergy.
- Osteoporosis or osteomalacia or other severe structural bone damage preventing the stable fixation of implant components;
- Insufficient blood supply and/or prior infection may slow healing and increase the likelihood of infection and/or rejection of implants;
- Any degenerative disease may adversely affect the proper placement of the implant;
- Healthy tissue can’t be fully covered;
- Surgery is operated in an unsterilized environment;
- Implanted in a body part that is used to support body weight or bear a heavy load.
- Patients with intra-cranial hypertension under clinical monitoring.
- Circulatory problems, systemic diseases and metabolic disorders.
- Bone tumors located in the implant base region.
- Obvious drug or alcohol abuse.
Possible Side Effects
- Osteoporosis and/or osteonecrosis resulting due to mechanical stress;
- Nerve and vascular injuries;
- Allergy to the implant or material;
- Nerve damage resulting from surgical injury;
- Bending or breaking of the implant;
- Movement or loosening of the implant;
- Pain, discomfort and/or other abnormal feelings resulting from the existence of the implant;
- Early and late infections, Surface and/or deep tissue infection;
- Surface skin doesn’t grow well;
- Wear and tear, fracture, deformation, loosening or migration due to impact of inappropriate forces or excessive weight loads.
- Hematoma and slow wound healing.
- Reduced joint function and mobility.
- Increased reaction of the fibrous tissue around the defect site and/or implant.
- Poor healing.
- Tissue discoloration.
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