3i T3® DCD® BNST411Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00844868029151), received between Sep 30, 2019 and Sep 14, 2026 — classified as 25 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain since implant placement. The patient returned for a follow-up today and stated that the pain had decreased over the past 2 days, but the gums were sore to touch. The implant failed to integrate and an infection was observed. As a consequence, the implant was removed, the infection was cleaned, and a bone graft was placed. Tooth site 11. Patient suffered from pain.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50750984 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at Tooth Site 12 was removed due to peri-implantitis. Inflammation was also reported.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50055264 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA AND PAIN.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 24058510 ↗
• InjuryNov 10, 2025Fracture; Fracture

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

  Patient problems: Inflammation; Pain

  MAUDE report 23508545 ↗
• InjuryMay 24, 2025Adverse 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. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA INFECTION. TOOTH SITE: #12.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 22082222 ↗
• InjuryMar 25, 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 #8 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21690304 ↗
• InjuryMar 20, 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 SITES #23, #24 AND #26 WERE REMOVED DUE TO PERI-IMPLANTITIS AND EXPOSED NECROTIC BONE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 21660111 ↗
• InjuryMar 20, 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 SITES #23, #24 AND #26 WERE REMOVED DUE TO PERI-IMPLANTITIS AND EXPOSED NECROTIC BONE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 21660096 ↗
• InjuryMar 20, 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 SITES #23, #24 AND #26 WERE REMOVED DUE TO PERI-IMPLANTITIS AND EXPOSED NECROTIC BONE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 21660064 ↗
• InjuryMar 12, 2025Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation

  MAUDE report 21584742 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER 34 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21544805 ↗
• InjuryJan 21, 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 #29 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION AND EDEMA.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21200663 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CALLED THE OFFICE STATING THAT THE IMPLANT AT TOOTH SITE #21 FELL OUT WHILE AT HOME. THE IMPLANT FELL OUT DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & PURULENT EXUDATE.

  Patient problems: Inflammation; Osteolysis; Purulent Discharge

  MAUDE report 21167513 ↗
• InjuryNov 29, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20809746 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #36 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20308324 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: III. THE DOCTOR REPORTED : SMOKER + POOR ORAL HIGYENE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19817426 ↗
• InjuryJul 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED ABSCESS FORMATION AFTER 8 WEEKS, RADIOLOGICAL BONE LOSS, INFLAMMATION AND INFECTION AT TOOTH SITE 15. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19673400 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 26 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteomyelitis; Unspecified Infection

  MAUDE report 19367110 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #24 AND #25 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17764265 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE TIME OF IMPLANT PLACEMENT, THE CORTICAL VESTIBULAR BONE WAS FRACTURED.

  Patient problems: Bone Fracture(s)

  MAUDE report 15285568 ↗
• InjuryMay 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT AT TOOTH SITE #31 WAS REMOVED DUE TO LACK OF PRIMARY STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905578 ↗
• InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE BNST411 IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH LOCATION # 27.

  Patient problems: Unspecified Infection

  MAUDE report 10953731 ↗
• InjurySep 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT HAD NO PRIMARY STABILITY AND WAS REMOVED. BONE GRAFT WAS PERFORMED. THREE MONTHS LATER, ANOTHER IMPLANT WAS PLACED.

  Patient problems: No Information

  MAUDE report 10498974 ↗
• InjurySep 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT WAS REMOVED DUE TO LOSS OF INTEGRATION WITH PERI-IMPLANTITIS. PATIENT ALSO HAD ABCESS, EDEMA, INFLAMMATION AND PAIN.

  Patient problems: Abscess; Edema; Inflammation; No Code Available; Pain; Unspecified Infection

  MAUDE report 10498666 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PRIMARY STABILITY WAS NOT ACHIEVED FOR IMPLANT BNST411. AREA WAS DEBRIDED AND GRAFTED. TOOTH SITE # 11.

  Patient problems: No Information

  MAUDE report 9137286 ↗