Long-term Safety and Performance of CMF Porous Titanium Implants

The loss of bone substance or continuity in the cranial and/or facial region can result from trauma, infection, benign or malign tumor resection, and therapeutic side effects (e.g., radiotherapy). CMF Porous Titanium Implants are patient-specific solutions matched with the patient's anatomy to reconstruct bone defects accurately. Following a premarket clinical evaluation and considering long-term risk management, the decision to conduct a retrospective post-market clinical follow-up study was based on identifying possible residual risks and uncertainty about long-term safety and clinical performance that may impact the benefit/risk ratio of the CMF porous titanium devices, thereby ensuring the continued safety and efficacy of these CMF devices.

• Perioperative complications related and unrelated to CMF Porous Titanium Implants [Срок оценки: Up to the moment the patient is discharged from the hospital after the procedure (discharge), up to several weeks, depending on defect severity and recovery progress]
• General post-operative complications up to standard of care (SOC) follow-up [Срок оценки: 4 weeks, 3 months, 1 year, 2-3 years, up to 8 years follow-up]
• Re-intervention rate, implant-related or not [Срок оценки: Up to 8 years follow-up]
• Intraoperative blood loss (mL) [Срок оценки: At procedure]
• Technical success of the implantation [Срок оценки: At procedure]
• Accuracy of the device implantation compared to the pre-operative plan [Срок оценки: 4 weeks follow-up]
• Implant migration [Срок оценки: 3 months, 1 year follow-up]
• Implant time of the device [Срок оценки: From surgery up to 8 years]
• Surgical operation time [Срок оценки: At procedure]
• Total hospital post-operative stay [Срок оценки: Up to the moment the patient is discharged from the hospital after the procedure (discharge), up to several weeks, depending on defect severity and recovery progress]