Craniofit^® Customized PEEK plates

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.

Contraindications:

1. Patients associated with serious systemic infection or systemic disease, such as serious diseases of heart, lungs, liver, kidney, hematopoietic systems and so on;
2. Due to physical or psychological reason, the patient doesn’t want to or can’t follow the doctor’s instructions for recovery; 
3. Patients with foreign body allergy. 
4. Osteoporosis or osteomalacia or other severe structural bone damage preventing the stable fixation of implant components; 
5. Insufficient blood supply and/or prior infection may slow healing and increase the likelihood of infection and/or rejection of implants; 
6. Any degenerative disease may adversely affect the proper placement of the implant; 
7. Healthy tissue can’t be fully covered; 
8. Surgery is operated in an unsterilized environment; 
9. Implanted in a body part that is used to support body weight or bear a heavy load. 
10. Patients with intra-cranial hypertension under clinical monitoring. 
11. Circulatory problems, systemic diseases and metabolic disorders. 
12. Bone tumors located in the implant base region. 
13. Obvious drug or alcohol abuse.

Possible Side Effects 

1. Osteoporosis and/or osteonecrosis resulting due to mechanical stress; 
2. Nerve and vascular injuries; 
3. Allergy to the implant or material; 
4. Nerve damage resulting from surgical injury; 
5. Bending or breaking of the implant; 
6. Movement or loosening of the implant; 
7. Pain, discomfort and/or other abnormal feelings resulting from the existence of the implant; 
8. Early and late infections, Surface and/or deep tissue infection; 
9. Surface skin doesn’t grow well; 
10. Wear and tear, fracture, deformation, loosening or migration due to impact of inappropriate forces or excessive weight loads. 
11. Hematoma and slow wound healing. 
12. Reduced joint function and mobility. 
13. Increased reaction of the fibrous tissue around the defect site and/or implant. 
14. Poor healing. 
15. Tissue discoloration.