3i T3® DCD® BNST410Recalls & reported problems
ZimVie US Corp LLC · 3i T3® WITH DCD® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 10MM · Class 2 · Implant
All models of 3i T3 DCD (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a 3i T3 DCD endosseous dental implant, a small screw-like implant used as a tooth root replacement. The 48 reports mostly describe implants that became infected (peri-implantitis), loosened, or lost surrounding bone and had to be removed and grafted, with bleeding, swelling, pain and numbness mentioned. There are 45 injuries and no deaths. No recalls name this device. Reports fell sharply in the past 12 months, from 9 to 2.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00844868029144), received between Oct 15, 2019 and Apr 17, 2026 — classified as 45 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (4 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem43
- Mechanical Problem4
- Difficult to Insert1
- Loss of Osseointegration1
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection31
- Osteolysis29
- No Clinical Signs, Symptoms or Conditions8
- Inflammation5
- No Information4
- Pain4
- Swelling/ Edema4
- No Code Available2
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS NOTED TO BE LOOSE AT THE ONE MONTH FOLLOW-UP EXAMINATION AND WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24915514 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT O/O BLEEDING AROUND IMPLANT; ABUTMENT PLACED (B)(6) 2022. RETURNED WITH PROBING, NO MOBILITY OF IMPLANT (B)(6) 2024. REMOVED AND GRAFTED (B)(6) 2025. TOOTH NUMBER 29. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, BLEEDING.
Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis; Unspecified Infection
MAUDE report 24735521 ↗InjuryJun 12, 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 #17 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22191804 ↗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. TOOTH SITE: #11.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22082234 ↗InjuryMay 23, 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 #20 FAILED THE STABILITY TEST AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 22080386 ↗InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT REPORTED SLIGHT LOWER RIGHT UP NUMBNESS. REMOVED AND GRAFTED. TOOTH 28. SYMPTOMS AS A RESULT OF THE EVENT: PARESTHESIA.
Patient problems: Nerve Damage; Paresthesia
MAUDE report 21934369 ↗InjuryApr 26, 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 # 30 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 21915427 ↗InjuryMar 6, 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 #27 FAILED DUE TO AN INFECTION AND IMPLANT WAS REMOVED. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 21535806 ↗InjuryJan 17, 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 #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21184010 ↗InjuryNov 30, 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 #16 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 20813694 ↗InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20614007 ↗InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 35, 37 WERE REMOVED DUE TO PERI-IMPLANTITIS AFTER PROSTHESIS PLACEMENT. INFLAMMATION, EDEMA AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 20349882 ↗InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 35, 37 WERE REMOVED DUE TO PERI-IMPLANTITIS AFTER PROSTHESIS PLACEMENT. INFLAMMATION, EDEMA AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 20349820 ↗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 #27 FAILED DUE TO PERI-IMPLANTITIS AND WAS REMOVED. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20308278 ↗MalfunctionSep 17, 2024Mechanical Problem; Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20235620 ↗InjuryAug 23, 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 #17 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20046358 ↗MalfunctionAug 22, 2024Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20035276 ↗InjuryJul 15, 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 46 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED : INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 19742695 ↗InjuryJan 11, 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 # 29 WAS REMOVED DUE TO BONE LOSS AND INFECTION AT THE IMPLANT SITE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN & SWELLING.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 18497723 ↗InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17948672 ↗InjurySep 28, 2023Adverse 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 #16 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17833335 ↗InjurySep 19, 2023Adverse 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 #22 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. SITE PRESENTED AN ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17771192 ↗InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #19. THE IMPLANT WAS TENDER TO PALPATION, THE GENERAL DOCTOR OF DENTAL SURGERY (DDS) NOTICED THERE WAS PURULENCE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS, BUT THE IMPLANT WAS REMOVED AS THE INFECTION WAS STILL ONGOING.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 17741359 ↗InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE SITE WAS GRAFTED WITH BONE GRAFT PLACED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17551061 ↗InjuryJun 13, 2023Adverse 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 BONE LOSS. THE SITE WAS ALLOGRAFTED.
Patient problems: Osteolysis
MAUDE report 17120950 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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