3i T3® BOST510Recalls & reported problems
ZimVie US Corp LLC · 3i T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie 3i T3 dental implant is a screw-shaped implant placed in the jawbone to support a replacement tooth. Many of the 112 reports describe infection and bone loss around the implant, with implants removed for peri-implantitis, a gum infection around the implant. The reports include 108 injuries and no deaths. 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
- 112
- Deaths reported
- 0
- Injuries reported
- 108
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 00844868029656), received between Aug 20, 2019 and Jul 31, 2026 — classified as 108 injuries, 4 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 Problem106
- Mechanical Problem2
- Component Missing1
- Device Damaged by Another Device1
- Patient-Device Incompatibility1
- Unsealed Device Packaging1
Patient problems
- Unspecified Infection76
- Osteolysis60
- Inflammation32
- Pain27
- No Clinical Signs, Symptoms or Conditions10
- Swelling/ Edema10
- Abscess8
- No Code Available4
Recent adverse event reports
The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient has infection, implant removed due to peri-implantitis and allowed to heal. Tooth site 6.Noted inflammation and bone loss.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50096433 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported a Periimplantitis. Implant was removed. Tooth site 26.Bone Type: III.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50081638 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the dental implants at Tooth Locations 14 and 16 failed due to peri-implantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50050969 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #37 WAS REMOVED DUE TO PERI-IMPLANTITIS. NO IMPACT ON THE PATIENT WAS REPORTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24801799 ↗InjuryMar 16, 2026Adverse 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 24604956 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24455109 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED COMPLAINING OF PAIN. THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS. THE PATIENT OPTED TO WAIT ON THE SITE TO BE GRAFTED IN ORDER TO TURN OVER. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 24390217 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 HAD NO INTEGRATION AND WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.
Patient problems: Osteolysis; Pain; Swelling/ Edema
MAUDE report 24304832 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 FAILED DUE TO INFECTION IN THE BONE. THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 24256961 ↗InjuryDec 22, 2025Device Damaged by Another Device; Device Damaged by Another Device
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO HEX DAMAGED. THEY PLACED ANOTHER IMPLANT DURING THE SAME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23861920 ↗InjuryNov 12, 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. AREA INFECTED SO DID NOT HEAL SYMPTOMS AS A RESULT OF THE EVENT: PAIN & SWELLING.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 23531275 ↗InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LOCALIZED MODERATE TO ADVANCED PERI-IMPLANTITIS AT TOOTH SITE #3. THE IMPLANT WAS REMOVED. AN ALLOGRAFT WAS PLACED WITH THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION AND BONE LOSS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23480479 ↗InjuryMay 24, 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: INFLAMMATION, PAIN & SWELLING.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22082075 ↗InjuryMay 22, 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 # 46.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22073537 ↗InjuryMay 21, 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 INFECTION. TOOTH SITE # 46.
Patient problems: Unspecified Infection
MAUDE report 22066703 ↗InjuryMay 19, 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 #45 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22045889 ↗InjuryMay 19, 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 #46 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22045586 ↗InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS BONE LOSS AND INFECTION AROUND THE PLATFORM OF THE IMPLANT AT TOOTH LOCATION #19. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21733204 ↗InjuryMar 18, 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.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21635469 ↗InjuryFeb 18, 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: Nerve Damage; Paresthesia
MAUDE report 21392602 ↗InjuryFeb 13, 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 BONE LOSS.
Patient problems: Osteolysis
MAUDE report 21379072 ↗InjuryFeb 12, 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: Osteolysis; Pain
MAUDE report 21363124 ↗InjuryJan 31, 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 #36 WAS REMOVED DUE TO INFECTION. PATIENT HAD IMPLANT PROCEDURE WITHOUT PROBLEM, REPORTED INFECTION 2 WEEKS AFTER PROCEDURE. IMPLANT REMOVED BECAUSE IT WAS MOBILE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 21283320 ↗InjuryJan 31, 2025Adverse 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: Inflammation; Swelling/ Edema; Unspecified Infection
MAUDE report 21282767 ↗InjuryJan 29, 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: Osteolysis; Pain; Unspecified Infection
MAUDE report 21267171 ↗
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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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