T3 T3PT6585Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00844868046851), received between Jul 13, 2023 and May 26, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 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 #5 WAS REMOVED DUE TO BONE LOSS. A FULL THICKNESS FLAP WITH A PAPILLA SPARING RELEASE WAS REFLECTED. THE OSTEOTOMY WAS DEBRIDED OF ALL SOFT TISSUE DOWN TO HEALTHY BONE. ALL FOUR BONY WALLS AND THE SINUS FLOOR WERE NOTED TO BE INTACT. DECORTICATED. OSTEOTOMES WERE THEN USED TO DISPLACE APICAL BONE SUPERIORLY. CO/CA/XE REGENEROSS BONE MIXED WITH PRF EXUDATE WAS PLACED IN THE OSTEOTOMY AND ALSO DISPLACED SUPERIORLY. CO/CA/XE REGENEROSS BONE MIXED WITH PRF EXUDATE WAS USED TO GRAFT THE OSTEOTOMY. A PRF MEMBRANE WAS PLACED OVER THE SITE AND SECURE WITH 3-0 GUT SUTURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 25278216 ↗
• MalfunctionMar 30, 2026Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED AS IT HAD DAMAGED THREADS. DR STATED THE CAUSE FOR FAILURE WAS THE IMPLANT'S THREADS WERE STRIPPED. UPON PLACEMENT AND TORQUING IMPLANT INTO PLACE THE INTERNAL CONNECTION STRIPPED. THE INTERNAL OF THE IMPLANT WAS DAMAGED AND THE IMPLANT HAD TO BE REMOVED THE PROCEDURE COMPLETED USING ANOTHER IMPLANT. DUE TO IMPLANT INTERNAL FAILURE, THE PROCEDURE WAS PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735098 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 16 WAS REMOVED DUE TO A PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24323644 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH PAIN AND LOOSENESS AROUND THE IMPLANT AT TOOTH SITE #2. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 24298518 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis

  MAUDE report 24086954 ↗
• InjuryJan 15, 2026Adverse 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. THE BONE LOSS SURROUNDING THE IMPLANTS WERE PRIOR TO RESTORATION. AFTER A PERIOD OF FOUR MONTH TIME PERIOD, IMPLANT REPLACEMENTS ARE ANTICIPATED.

  Patient problems: Osteolysis

  MAUDE report 24086689 ↗
• InjuryDec 1, 2025Adverse 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: Osteolysis

  MAUDE report 23689449 ↗
• InjuryNov 25, 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 #46 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 23649238 ↗
• InjuryJun 13, 2025Adverse 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 INFECTION. TOOTH LOCATION IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22206104 ↗
• InjuryMay 1, 2025Adverse 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945178 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED 3.5 MONTHS POST-OPERATIVE IMPLANT PLACEMENT AT TOOTH LOCATION #3 AND CLOSED SINUS LIFTING. PA WAS TAKEN AND MESIAL BONE ATROPHY WAS NOTED. THE IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 19300879 ↗
• InjuryJul 13, 2023Adverse 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: Osteolysis; Pain

  MAUDE report 17317978 ↗