Eztetic™ CM318Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024343627), received between Nov 7, 2020 and Jan 13, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #31 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24053435 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE HEALING PERIOD, THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO INFECTION. PATIENT EXPERIENCED PAIN. ANOTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23736611 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #22 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD AN ABSCESS. DOCTOR REPORTED OVER THE PHONE THAT THE EVENT HAPPENED 14 MONTHS AFTER LOADING THE IMPLANT, DATE OF LOADING (B)(6) 2024.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23736397 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PERI-IMPLANTITIS AT TOOTH SITE 41 AND THE IMPLANT WAS REMOVED. ABSCESS, PAIN, INFLAMMATION AND EDEMA WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 21593535 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #22 WAS REMOVED DUE TO PERI-IMPLANTITIS. EDEMA AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 19793464 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #46 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19296315 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH LOCATION #44 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT CAME WITH AN ABSCESS AND INFLAMMATION IN THE SITE AND WHEN CHECK UP IT WAS NOTICED THE PERI-IMPLANTITIS. BONE TYPE II.

  Patient problems: Osteolysis; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 17623228 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #47 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 15982145 ↗
• InjuryMay 19, 2022Unsealed Device Packaging; Unsealed Device Packaging

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14447286 ↗
• InjuryJan 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT FOUND HIS IMPLANT CROWN LOOSE, AFTER THE EXAM IT WAS NOTICED THAT THE REASON WAS FRACTURE IN THE IMPLANT BODY. FLOWERING. THE IMPLANT WAS REMOVED DUE TO FRACTURED IMPLANT. TOOTH SITE # 19 (UNIVERSAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13383867 ↗
• InjuryNov 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE CM318 IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS. TOOTH SITE #3.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10805955 ↗