3i T3® BOPT4313Recalls & reported problems
ZimVie US Corp LLC · 3i T3® TAPERED IMPLANT 4/3 X 13MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This 3i T3 dental implant replaces a missing tooth root. The 86 reports mostly describe implants that had to be removed after infection around the implant, bone loss, pain, and abscess, with no deaths and 84 injuries. No recalls name this device. Recent report volume is steady, with 5 reports in the last 12 months versus 7 the year before.
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
- 86
- Deaths reported
- 0
- Injuries reported
- 84
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00844868028482), received between Apr 9, 2020 and May 20, 2026 — classified as 84 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem84
- Mechanical Problem2
- Failure to Osseointegrate1
- No Flow1
Patient problems
- Unspecified Infection58
- Osteolysis40
- Pain22
- Inflammation17
- Abscess13
- No Clinical Signs, Symptoms or Conditions8
- Swelling/ Edema8
- No Information7
Recent adverse event reports
The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25231189 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #13 AND #23 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 25190968 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #13 AND #23 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 25190879 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #25 AND #26 WERE REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANTS HAVE FAILED AND CAME OUT ALONG WITH THE PROSTHETIC RESTORATION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24866040 ↗InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS. ANOTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE.
Patient problems: Osteolysis
MAUDE report 24433152 ↗InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. AFTER PLACEMENT INFECTION WAS FOUND AROUND THE FIXTURES. TOOTH SITES UL2-UR3.
Patient problems: Unspecified Infection
MAUDE report 23441405 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 15 WAS REMOVED DUE TO PERI-IMPLANTITIS. DOCTOR ALSO INDICATED 2/3 BONE LOSS. PAIN, ABSCESS AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21983171 ↗InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE 14 OBSERVED DURING THE CLINICAL PROCEDURE AND THE IMPLANT WAS REMOVED. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT. BONE GRAFT WAS PERFORMED. THE PROCESS WILL BE COMPLETED WITH ANOTHER IMPLANT (WHEN CICRATIZATION OCCURS).
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21707702 ↗InjuryJan 9, 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 #5 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21117980 ↗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; Unspecified Infection
MAUDE report 20976489 ↗InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #24-25. IMPLANTS WERE REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20794537 ↗InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #24-25. IMPLANTS WERE REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20793958 ↗InjurySep 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 #4 WAS REMOVED DUE TO INFECTION. PATIENT PRESENT FOR SURGICAL RELEASE, IMPLANT AREA INFECTED AND IMPLANT NOT INTEGRATED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & EDEMA.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 20181803 ↗InjuryJul 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 #28 WAS REMOVED DUE TO INFECTION. BUCCAL AND SWELLING TWO WEEKS AFTER IMPLANT WAS PLACED. REMOVAL TO STOP PAINSYMPTOMS AS A RESULT OF THE EVENT: PAIN & EDEMA
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 19694906 ↗InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS IN PAIN ON THE DAY OF IMPLANT PLACEMENT AND THE PATIENT CAME BACK A WEEK LATER DUE TO PAIN. THE IMPLANT AT TOOTH SITE #29 WAS REMOVED.
Patient problems: Pain
MAUDE report 19561348 ↗InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #8 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Unspecified Infection
MAUDE report 19481767 ↗InjuryMay 13, 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 22 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: UNKNOWN. THE DOCTOR REPORTED : INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 19296243 ↗InjuryMay 6, 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: Sinus Perforation
MAUDE report 19248125 ↗InjuryMar 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. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 18957461 ↗InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN SITE 22 WAS REMOVED DURING FINAL CHECK DUE TO SIGNIFICATE BONE LOSS.
Patient problems: Osteolysis
MAUDE report 18564863 ↗InjuryJan 7, 2024Adverse 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 18461379 ↗InjuryJan 2, 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 #6 WAS REMOVED DUE TO AN INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA & INFLAMMATION
Patient problems: Unspecified Infection
MAUDE report 18427725 ↗InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PT CALLED STATING HER FACE WAS SWOLLEN. PT CAME IN AND IMPLANT SITE WAS INFECTED. TOOTH #9. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 18422147 ↗InjuryDec 15, 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 #6. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 18333211 ↗InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED PATIENT HAD EXTRACTION AND IMMEDIATE IMPLANT AND RETURNED WITH AN INFECTION, TOOTH 12. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Unspecified Infection
MAUDE report 18247826 ↗
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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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