3i T3® BOPT6510Recalls & reported problems
ZimVie US Corp LLC · 3i T3® TAPERED IMPLANT 6/5 X 10MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This 3i T3 tapered endosseous dental implant is a screw-shaped root-form implant used to anchor a replacement tooth in the jaw. The 66 reports mostly describe implants that had to be taken back out because of infection around the implant, bone loss, inflammation and pain, along with a few mechanical problems such as stripped or fractured implants. No deaths were reported; 58 reports involved injuries and 8 malfunctions. Reports dropped from 11 in the prior 12 months to 1 in the most recent 12 months. 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
- 66
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00844868029854), received between Dec 3, 2019 and Jan 15, 2026 — classified as 58 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (13 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 Problem52
- Mechanical Problem13
- Fracture1
Patient problems
- Osteolysis30
- Unspecified Infection27
- Pain18
- No Clinical Signs, Symptoms or Conditions13
- Inflammation12
- No Code Available4
- No Information4
- Swelling/ Edema3
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24079692 ↗InjuryJun 19, 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 PERIIMPLANTITIS. CUSTOMER REPORTED BONE LOSS/PERIIMPLANTITIS, TOOTH 19. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22292634 ↗InjuryJun 19, 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 PERIIMPLANTITIS. CUSTOMER REPORTED BONE LOSS/PERIIMPLANTITIS, TOOTH 18. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22292512 ↗InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #47. PAIN WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22209297 ↗InjuryJun 3, 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 PAIN DURING PHASE II (UNCOVERING) PROCEDURE. TOOTH #30.
Patient problems: Pain
MAUDE report 22132745 ↗InjuryMay 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 #3 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 22120475 ↗MalfunctionApr 17, 2025Mechanical Problem; Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21860458 ↗MalfunctionApr 3, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED STRIPPED IMPLANT, TOOTH 30. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21764549 ↗InjuryFeb 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 #14 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 21446679 ↗InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 18 AND 19 WERE REMOVED DUE TO BONE LOSS. IMPLANTS PLACED ON (B)(6) 2024 WITH HEALING DENTURES. RETURNED (B)(6) 2024 FOR TORQUE TEST AND SEVERE BONE LOSS NOTED, 50% IMPLANT EXPOSURE FROM MID IMPLANT, SUPERIORLY. IMPLANTS REMOVED AND SITE GRAFTED. ADDITIONAL APPOINTMENT IS REQUIRED TO REPLACE IMPLANTS.
Patient problems: Osteolysis
MAUDE report 20923171 ↗InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION, TOOTH 31.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20908079 ↗InjuryDec 4, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO THE IMPLANT HAVING DAMAGED THREADS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 20842195 ↗MalfunctionOct 28, 2024Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20549311 ↗InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH #47/26 WERE REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20543359 ↗InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH #47/26 WERE REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20543341 ↗InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #37 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 20543265 ↗InjuryOct 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 #3 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: SINUS COMMUNICATION
Patient problems: Osteolysis; Sinus Perforation
MAUDE report 20355296 ↗InjuryOct 1, 2024Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 20347417 ↗InjuryAug 9, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED CROWN INSTABILITY. UPON CLINICAL EVALUATION, IT WAS FOUND IMPLANT MALFUNCTION. CLINICIAN TRIED TO SEAT ABUTMENT BUT INTERNAL HEX OF THE IMPLANT DISTORTED. COULD NOT SEAT ENCODE. IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19954974 ↗InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED SEVERE MESIAL BONE LOSS NOTED AFTER 6 YEARS.
Patient problems: Osteolysis
MAUDE report 19819089 ↗InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERI-IMPLANTITIS, FAILED IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19721877 ↗InjuryJun 7, 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 POOR BONE FORMATION. TOOTH #19.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19489722 ↗InjuryMay 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 # 46 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19231709 ↗InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN/SORENESS ON/AROUND IMPLANT TOOTH SITE #18. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Pain
MAUDE report 19085512 ↗InjuryMar 20, 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 # 3 SUFFERED FROM INFECTION AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION; & PAIN.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 18946612 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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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