3i T3® BOSS410Recalls & reported problems
ZimVie US Corp LLC · 3i T3® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 10MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This 3i T3 dental implant is a small screw-shaped implant used to replace a missing tooth root in the jaw. The 33 reports describe implants loosening or breaking, often with infection around the implant, bone loss, pain, or the implant having to be removed; no deaths were reported and 33 injuries were. No recalls name this device, and report numbers were steady at 6 in each of the last two 12-month periods.
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
- 30
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00844868028819), received between Aug 31, 2020 and Aug 23, 2026 — classified as 30 injuries.
The most frequently reported specific device problem is “Component Missing” (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 Problem27
- Component Missing1
- Fracture1
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection17
- Osteolysis13
- Pain6
- Abscess4
- Inflammation4
- No Clinical Signs, Symptoms or Conditions4
- Hypersensitivity/Allergic reaction2
- Nerve Damage2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2026Adverse Event Without Identified Device or Use Problem
Doctor reported that implant was removed due to Peri-implantitis after chemotherapy.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50393349 ↗InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS PLACED (PREVIOUS DR REMOVED TOOTH SIX MONTHS PRIOR). UNEVENTFUL PROCEDURE, UNEVENTFUL INITIAL POST OP. THE PATIENT RETURNED TO BRUSHING AND ROUTINE DIET. THE PATIENT RETURNED WITH THE IMPLANT IN HAND. PATIENT REMOVED THE IMPLANT AT HOME AFTER EATING BREAD. THE IMPLANT CAME OUT DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25116685 ↗InjuryNov 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 #11 WAS REMOVED AS THE IMPLANT WAS LOOSE DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 23454739 ↗InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #35 DETECTED WHILE LOADING THE IMPLANT. IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22209641 ↗InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 26 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21907716 ↗InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 16 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21749820 ↗InjuryFeb 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Osteolysis; Pain
MAUDE report 21293459 ↗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: Erosion; Hypersensitivity/Allergic reaction; Osteolysis
MAUDE report 21283025 ↗InjuryNov 28, 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 #15 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: III. THE DOCTOR REPORTED : INFECTION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20805413 ↗InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Nerve Damage; Paresthesia
MAUDE report 20406486 ↗InjuryAug 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 SITE #4 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 20032429 ↗InjuryAug 20, 2024Component Missing; Component Missing
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20003850 ↗InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS AT TOOTH SITE 15.
Patient problems: Osteolysis
MAUDE report 19151533 ↗InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Nerve Damage; Paresthesia
MAUDE report 18684111 ↗InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 26 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION AND PAIN.
Patient problems: Inflammation; Pain
MAUDE report 18398245 ↗InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 17098666 ↗InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT DURING IMPLANTATION AT TOOTH SITE 13 THE VESTIBULAR BONE SLAT FRACTURED. NO OTHER IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANTATION AFTER HEALING.
Patient problems: Bone Fracture(s)
MAUDE report 15980518 ↗InjuryOct 14, 2022Fracture; Fracture
DOCTOR REPORTED THAT THE IMPLANT FRACTURED AT TOOTH LOCATIONS 46 AND 44. PATIENT WOULD HAVE TO RETURN TO PLACE NEW IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15608053 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO AN INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 15324340 ↗InjuryAug 5, 2022Adverse 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 WITH BONE LOSS, INFECTION, AN ABSCESS, PAIN, SWELLING AND PURULENT DISCHARGE.
Patient problems: Abscess; Osteolysis; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection
MAUDE report 15174655 ↗InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ROUTINE X-RAYS SHOWED APICAL PATHOLOGY AT APEX OF FIXTURE; ENTERED AREA & WAS ABLE TO BACK FIXTURE OUT. IMPLANT WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13560510 ↗InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 13018714 ↗InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT WAS UNABLE TO PLACE DUE TO A LACK OF PRIMARY STABILITY AND WAS REMOVED. NO OTHER IMPLANT HAS BEEN PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12787001 ↗InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Abscess; Inflammation; Unspecified Infection
MAUDE report 12244268 ↗InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 13 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. PATIENT LIKELY RETURNING FOR IMPLANT REPLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: NONE REPORTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 12036928 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- 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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