3i T3® DCD® BNPT5410Recalls & reported problems
ZimVie US Corp LLC · 3i T3® WITH DCD® TAPERED IMPLANT 5/4 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 ZimVie 3i T3 with DCD tapered dental implant, a screw-shaped root-form implant used to replace a tooth. The 48 reports mostly describe implants that became loose or were removed after infection around the implant (peri-implantitis), with patients reporting pain, bone loss, and drainage; a few mention the implant shifting position or breaking. No deaths were reported, and 46 injuries were. No recalls name this device.
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
- 46
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00844868028369), received between Feb 28, 2020 and Apr 3, 2026 — classified as 46 injuries, 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem46
- Fracture1
- Loss of Osseointegration1
- Mechanical Problem1
Patient problems
- Unspecified Infection30
- Osteolysis17
- Pain17
- No Information5
- Inflammation4
- No Clinical Signs, Symptoms or Conditions4
- No Code Available3
- Erosion2
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S DENTIST REQUESTED EXAMINATION OF THE IMPLANT AT TOOTH SITE #3. THE IMPLANT WAS MOBILE AND HAD FAILED DUE TO PERI-IMPLANTITIS AND WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 24781937 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CBCT WAS TAKEN OF THE DENTAL IMPLANTS AT TOOTH SITE #3 AND #4 AFTER THE PATIENT COMPLAINED OF HAVING PAIN AROUND THE IMPLANTS. IT WAS ALSO REPORTED THAT IMPLANT #4 HAD MIGRATED DOWN AND IMPLANT #3 HAD MIGRATED UP. THE IMPLANTS WERE REMOVED DUE TO INFECTION.
Patient problems: Pain; Unspecified Infection
MAUDE report 24394142 ↗InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN AT TOOTH SITE #18. THE PATIENT WENT TO SEE THE ENDO TO SEE IF IT WAS ADJACENT TEETH AND IT WAS THE DENTAL IMPLANT CROWN STILL ATTACHED. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS REQUIRED WITH NO FURTHER DETAILS PROVIDED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24099210 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. TOOTH SITE: 20 SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23350457 ↗InjuryJun 30, 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 #3 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22353122 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22332878 ↗InjuryJun 3, 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 #18 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PURULENCE.
Patient problems: Inflammation; Purulent Discharge; Unspecified Infection
MAUDE report 22133382 ↗InjuryDec 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20974389 ↗InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 20491926 ↗InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20285506 ↗InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER 3 MONTHS A DRAINING FISTULA DEVELOPED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Unspecified Infection
MAUDE report 19832197 ↗InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED BONE LOSS AROUND THE IMPLANT AT TOOTH LOCATION #30. SINUS INFECTION WAS ALSO REPORTED. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA.
Patient problems: Osteolysis; Swelling/ Edema
MAUDE report 19808444 ↗InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WITH THE IMPLANT AT TOOTH LOCATION #3. THE IMPLANT WAS REMOVED DUE TO INFECTION.
Patient problems: Pain; Unspecified Infection
MAUDE report 19446637 ↗InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #14 WAS MOBILE DUE TO ADVANCED BONE LOSS. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 19260807 ↗InjuryApr 12, 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. TOOTH SITE # 30.
Patient problems: Unspecified Infection
MAUDE report 19095617 ↗InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. PATIENT WAS HAVING PAINT FROM IMPLANT PLACEMENT. TOOTH #30. SYMPTOMS, ABSCESS AND PAIN.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 18862254 ↗InjuryFeb 16, 2024Adverse 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 #30. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 18728151 ↗InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED RADIOLUCENCY AND INFECTION AROUND THE IMPLANT AT TOOTH LOCATION #19. THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 18493927 ↗InjuryDec 10, 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 #31. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18298698 ↗InjuryOct 26, 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 #3. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 18017367 ↗InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLINICIAN REPORTED PATIENT COMPLAINED OF DULL ACHE LEFT MANDIBLE APPROX 2 MONTHS LATER AFTER IMPLANT PLACEMENT. HEALING ABUTMENT WAS PLACED EARLY ON (B)(6) 2023 BUT SYMPTOMS PERSISTED AND IMPLANT WAS REMOVED ON (B)(6) 2023. WILL RETURN FOR POSSIBLE IMPARTMENT IN THE FUTURE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17341508 ↗InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #16 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOM AS A RESULT OF EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 17325636 ↗InjuryMay 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Nerve Damage
MAUDE report 16883747 ↗InjuryApr 25, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16811916 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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