T3 T3PT6511Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00844868046820), received between Dec 13, 2023 and Apr 8, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A POST-OP APPOINTMENT WITH COMPLAINTS OF INTENSE PAIN IN THE RIGHT POSTERIOR MANDIBLE AROUND THE IMPLANT AT TOOTH SITE #30. THE SURGICAL SITE WAS COVERED WITH SOFT TISSUE THAT WAS EDEMATOUS AND FLUCTUANT, PROMPTING AN INCISION TO ASSESS THE IMPLANT. BUCCAL BONE LOSS WAS NOTED WITH DEHISCENCE AND A PROBABLE 6 MM DEFECT IN THE BUCCAL PLATE. THE IMPLANT WAS EXPLANTED WITH A HAND SCREW AND ZERO RESISTANCE DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & EDEMA.

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 24817492 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis

  MAUDE report 24673521 ↗
• InjuryOct 29, 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: Osteolysis

  MAUDE report 23414926 ↗
• InjuryMar 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 #30 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 21590536 ↗
• InjuryFeb 3, 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; Osteolysis

  MAUDE report 21298129 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT PRESENTED WITH PAIN AND SINUS PRESSURE FOLLOWING SURGERY. PERFORATED SINUS, IMPLANT WAS REMOVED, ANTIBIOTIC PRESCRIBED. TOOTH 2 SYMPTOMS AS A RESULT OF THE EVENT: EDEMA, PAIN.

  Patient problems: Pain; Sinus Perforation; Swelling/ Edema

  MAUDE report 21217002 ↗
• InjurySep 19, 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 INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA & INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20255404 ↗
• InjuryJul 17, 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; Numbness; Paresthesia

  MAUDE report 19759741 ↗
• InjuryMar 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 19 WAS REMOVED DUE TO ALLERGIC REACTION. PT IS ALLERGIC TO TITANIUM

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18860398 ↗
• InjuryFeb 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT IS ALLERGIC TO TITANIUM, THEREFORE THE IMPLANT WAS REMOVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18639955 ↗
• MalfunctionDec 13, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED INTERNAL HEX OF IMPLANT WAS STRIPPED DURING PLACEMENT. IMPLANT WAS REMOVED AND REPLACED WITH ANOTHER ONE. TOOTH 30

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18323765 ↗