Eztetic™ CM3113Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00889024343603), received between Jul 16, 2020 and Mar 26, 2026 — classified as 34 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SECOND STAGE PROCEDURE. A PERIODONTAL ABSCESS WAS PRESENT AT TOOTH SITE #26. THE FLAP WAS RAISED AND SEVERE BONE LOSS TO APICAL WAS NOTED ON A THIRD OF THE IMPLANT. IT WAS REVERSE TORQUED BY HAND AND THE IMPLANT WAS REMOVED.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 24706383 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PHONE THAT THE IMPLANT AT TOOTH SITE #25 WAS REMOVED DUE TO BONE LOSS. THE PATIENT PRESENTED FOR A STAGE TWO PROCEDURE, BUT THE IMPLANT HADN'T TAKEN AND WAS LOOSE. IT WAS NOTED THAT THE THERE WAS A VERY NARROW RIDGE AND POOR BONE WHICH RESULTED IN EVEN MORE BONE LOSS OVER TIME.

  Patient problems: Osteolysis

  MAUDE report 24345281 ↗
• InjuryMar 7, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546916 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS BONE LOSS AROUND THE IMPLANT AT TOOTH LOCATION #7. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 21470342 ↗
• MalfunctionDec 18, 2024Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20961786 ↗
• MalfunctionDec 18, 2024Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20961714 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #23 WAS REMOVED DUE TO PERI-IMPLANTITIS. #23 IMMEDIATE IMPLANT 3.1 MM X 13 MM PLACED. IN 3 MONTHS, INFECTION CAUSED IMPLANT FAILURE. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT R ANOTHER DEVICE: NO. WAS THERE A DELAY DURING THE PROCEDURE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & EDEMA.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 20641356 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. TENDERNESS AT THE REGION, SITE #26. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 20183064 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #31. PATIENT FELT PAIN AROUND THE IMPLANT AND A FEW DAYS LATER SUFFERED A SPONTANEOUS EXPLANTATION. PATIENT SUFFERED INFLAMMATION AND PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19049482 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 18482868 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #20, WITH ASSOCIATED PAIN. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17867241 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN AGGRESSIVE INFECTION AT IMPLANT TOOTH SITE #30. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 17576658 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN EXAM AN INFECTION WAS OBSERVED A TOOTH SITE #7, AND THERE WAS TENDERNESS AT THE REGION. THE IMPLANT WAS REMOVED, AND THE SITE GRATED WITH ALLOGRAFT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 17556915 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16920225 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED CRESTAL/BUCCAL BONE LOSS AND INFECTION, TOOTH 10 (UNIVERSAL). IMPLANT WAS REMOVED AND SITE GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: PAN, EDEMA, AND INFLAMMATION. THE SITE WAS ALSO GRAFTED TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Inflammation; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16905350 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD IMPLANTS WAS REMOVED DUE TO PERI-IMPLANTITIS.SYMPTOMS CAUSED BY THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 16216051 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AT THE SITE WITH AN ABSCESS, PAIN AND INFLAMMATION. PATIENT WILL RETURN FOR A NEW IMPLANT.

  Patient problems: Abscess; Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 15261408 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE WAS AN INFECTION AT TOOTH SITE # 25 AND TENDERNESS AT THE DENTIN. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 14518558 ↗
• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT FAILED DUE TO BONE RESORPTION AFTER SIX MONTHS OF PLACEMENT. THE DOCTOR CONFIRMED THAT THE DENTAL SURGICAL PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH AS A CONSEQUENCE OF THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 14432873 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. TOOTH #25.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14322688 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Osteolysis

  MAUDE report 13513857 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 10 LACKED PRIMARY STABILITY, AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12900113 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 12597238 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT FAILED TO INTEGRATE DUE TO LACK OF PRIMARY STABILITY AND WAS REMOVED. THE SITE WAS GRAFTED. TOOTH LOCATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12502388 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED LACK OF PRIMARY STABILITY. NO OTHER IMPLANT WAS PLACED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340847 ↗