3i T3® BOET510Recalls & reported problems
ZimVie US Corp LLC · 3I T3® EX HEX TAPERED IMPLANT 5 X 10MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868033301), received between Jul 9, 2021 and Dec 11, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection4
- Osteolysis3
- No Clinical Signs, Symptoms or Conditions2
- Pain2
- Abscess1
- Discomfort1
- Hypersensitivity/Allergic reaction1
- Inflammation1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS FAILED DUE TO ALLERGIC REACTION & INFECTION. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.
Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection
MAUDE report 23776919 ↗InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS AT TOOTH SITE #34-44-46. PATIENT SUFFERED INFLAMMATION AND PAIN. IMPLANTS WERE REMOVED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21916672 ↗InjuryMay 31, 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 # 2 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17030166 ↗InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #47 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN, ABSCESS, SUPPURATION AND DISCOMFORT.
Patient problems: Abscess; Discomfort; Inflammation; Pain; Unspecified Infection
MAUDE report 16005776 ↗InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT IMPLANT FAILED BECAUSE IT DID NOT OBTAIN PRIMARY STABILITY. THE DOCTOR REPORTS THAT THE DENTAL SURGICAL PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANT AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12801871 ↗InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITES # 12, 14 WERE REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 12445856 ↗InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE #24 WAS UNABLE TO PLACE DUE TO A LACK OF PRIMARY STABILITY DURING THE SURGERY AND NO OTHER IMPLANT WAS PLACED AFTER THE FIRST ONE FAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12141863 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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