T3 T3ST485Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00844868046950), received between Jan 24, 2024 and Jul 28, 2026 — classified as 14 injuries.

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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the dental implants at Tooth Sites 34 and 36 failed due to peri-implantitis. Pain and inflammation were also reported.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50051308 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the dental implants at Tooth Sites 34 and 36 failed due to peri-implantitis. Pain and inflammation were also reported.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50051307 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 19 18 (ONE STAGE SURGERY) MOBILE. PAN SHOWED BONE LOSS AND IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 25246712 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #36 AND #37 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24562897 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24201743 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #9 WAS REMOVED DUE TO NERVE INJURY PAIN. PATIENT DEVELOPED NERVE PAIN AFTER CROWN PLACED. DID NOT GET BETTER ONCE CROWN WAS REMOVED. PATIENT REQUESTED EXTRACTION OF IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Nerve Damage; Pain

  MAUDE report 24065983 ↗
• InjuryMay 5, 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. ON IMPLANTATION DAY DOCTOR PEFORMED REGENERATION DUE TO VERSTIBULAR CRATER. DURING SECOND STAGE DOCTOR NOTICED GRANULATION TISSUE AROUND THE IMPLANT AND DECIDED TO REMOVE IT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21958047 ↗
• InjuryApr 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 BONE LOSS. REPORTED SOME BONE LOSS DURING INITIAL HEALING, SUPPURATION NOTED. ELECTED TO REMOVE IMPLANT. TOOTH SITE: 19.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis

  MAUDE report 21762281 ↗
• 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 #4 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21635257 ↗
• InjuryDec 11, 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 35,36,37 WERE REMOVED DUE TO INFECTION. INFLAMMATION AND PAIN REPORTED AS A CONSEQUENCE OF THE EVENT. OTHER IMPLANT PLACED ON (B)(6) 2024.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 20902195 ↗
• InjuryDec 11, 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 35, 36, 37 WERE REMOVED DUE TO INFECTION. INFLAMMATION AND PAIN REPORTED AS A CONSEQUENCE OF THE EVENT. OTHER IMPLANT PLACED ON (B)(6) 2024.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 20902076 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 46 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH STRONG INFLAMMATION. PATIENT REFERRED PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20503438 ↗
• InjuryMar 26, 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 47 WAS REMOVED DUE TO INFECTION TO AVOID DAMAGING THE AREA PERMANENTLY. INFLAMMATION, PAIN, EDEMA AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18978672 ↗
• InjuryJan 24, 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: Bone Fracture(s)

  MAUDE report 18573736 ↗