Reporting a Failed or Expired Implant

To ensure proper traceability and quality follow-up, all failed or expired CeraRoot implants must be reported using the official reporting form.

Step 1 — Submit the Reporting Form

Submit the form at: https://ceraroot.com/reporting/   using the following form.

• Each implant must be reported separately
• One form must be completed per implant
• If returning multiple implants, submit one form per implant

Step 2 — Receive Confirmation Email

• After submission, you will receive a confirmation email
• The email includes a Response Number
• This Response Number is required for the return process

Step 3 — Prepare the Implant

• The implant must be decontaminated before shipment
• Use a disinfectant intended for manual disinfection (e.g. ortho-phthalaldehyde solution)

Sterilization requirements:

• Use a sterilization pouch
• Steam sterilization at 132°C (270°F):

• 4 minutes (pre-vacuum method)
• 15 minutes (gravity method)
• Drying time:
• 20–30 minutes (pre-vacuum)
• 15–30 minutes (gravity)

Important:

• The sterilization pouch must show a completed sterilization cycle
• If sterilization is not possible, disinfect and place the product in a sterilization pouch

Step 4 — Label the Sterilization Pouch

Write clearly on the pouch:

• Product LOT
• Doctor’s last name
• Response Number
• Patient code or medical history number
• Do not include the patient’s full name