T3 T3ST585Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00844868047001), received between Apr 18, 2023 and May 26, 2026 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25280574 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 36 WAS REMOVED DUE TO INFECTION AND A BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24430310 ↗
• InjuryNov 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 #3 WAS PLACED WITH 25 N-CM PRIMARY STABILITY. OSSEOINTEGRATION WAS ACHIEVED BUT THERE WAS 5MM OF BONE LOSS ON THE BUCCAL. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 23593397 ↗
• InjuryJun 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 #3 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22283635 ↗
• InjuryFeb 6, 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 SINUS PERFORATION. PATIENT PRESENTED FOR ONE MONTH FOLLOW-UP AND STATED THAT AREA WAS SWOLLEN ONE WEEK EARLY AND HAD TO GO TO THE ER. UPON EXAM GRADES MOBILITY NOTED ON #3 IMPLANT (INTO SINUS LIFT SITE). SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.

  Patient problems: Erosion; Inflammation; Sinus Perforation

  MAUDE report 21328119 ↗
• InjuryOct 10, 2024Adverse 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: Pain

  MAUDE report 20416921 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DIABETIC WHO PRESENTED WITH AN INFECTION ASSOCIATED WITH THE IMPLANT, GRANULATION TISSUE AND ABSCESS. TOOTH #18. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 19713626 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT SUTURE REMOVAL, THE AREA AROUND THE IMPLANT AT TOOTH LOCATION #3 WAS TENDER AND SWOLLEN AND HEALING WAS SLOW OVER THE INCISIONAL LINE. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19567890 ↗
• InjuryMay 20, 2024Adverse 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: Pain; Sinus Perforation

  MAUDE report 19352635 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Osteolysis

  MAUDE report 17901602 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE IMPLANT AT TOOTH SITE # (B)(6) FAILED. AND WAS REMOVED, DUE TO PERI-IMPLANTITIS. THE SITE WAS CLEANED FOR HEALING. FOR FUTURE IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17461787 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #19 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16762951 ↗