T3 T3PT4313Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00844868046738), received between Jan 3, 2023 and Sep 29, 2026 — classified as 72 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fistula; Osteolysis; Swelling/ Edema

  MAUDE report 50933452 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that when switching cover screw for an encode healing abutment, infection was noticed and implant was loose. Patient had previous infection on the site which it was clean and treated but due to patient medical condition with low platelets count, the infection came back and 2 implants had to be removed due to peri-implantitis. This event refers to peri-implantitis of one tooth site unknown.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50931336 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to a large periapical infection at tooth site 26.Patient will return in 3 months.

  Patient problems: Unspecified Infection

  MAUDE report 50798703 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that extraction, bone grafting, and immediate implant placement for tooth #5 were performed on (b)(6) 2026. A cover screw was placed, and the area was left to heal. On (b)(6) 2026, during the second-stage procedure, significant bone loss was observed. As a consequence, the implant was removed, and the area was bone grafted again.No impact on the patient reported.

  Patient problems: Osteolysis

  MAUDE report 50751168 ↗
• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the implant at tooth site 24 was removed due to peri-Implantitis. Four implants placed 1 failed, develop infection and subsequent bone loss, the surgeon raised a buccal flap and found that the threads were exposed up half the implant. Implant was removed. Additional appointment required to replace implant in 5 months.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50264023 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the dental implant failed due to peri-implantitis.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50052921 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at Tooth Site 33 failed due to peri-implantitis.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50050893 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICIAN PLACED FOUR (4) DELAYED IMPLANTS AT TOOTH SITES #4, #8 #9 AND #12. THE PATIENT RETURNED FOR 2ND STAGE UNCOVERY AND NONE OF THE 4 IMPLANTS WERE INTEGRATED. THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND SWELLING.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25246802 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICIAN PLACED FOUR (4) DELAYED IMPLANTS AT TOOTH SITES #4, #8 #9 AND #12. THE PATIENT RETURNED FOR 2ND STAGE UNCOVERY AND NONE OF THE 4 IMPLANTS WERE INTEGRATED. THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND SWELLING.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25246731 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICIAN PLACED FOUR (4) DELAYED IMPLANTS AT TOOTH SITES #4, #8 #9 AND #12. THE PATIENT RETURNED FOR 2ND STAGE UNCOVERY AND NONE OF THE 4 IMPLANTS WERE INTEGRATED. THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND SWELLING.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25246609 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICIAN PLACED FOUR (4) DELAYED IMPLANTS AT TOOTH SITES #4, #8 #9 AND #12. THE PATIENT RETURNED FOR 2ND STAGE UNCOVERY AND NONE OF THE 4 IMPLANTS WERE INTEGRATED. THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND SWELLING.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25246473 ↗
• InjuryMay 18, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS AND POSSIBLE ALLERGIC REACTION. PATIENT CALLED COMPLAINING OF SYMPTOMS ASSOCIATED WITH IMPLANT SITE. PATIENT REJECTED IMPLANT AND THE GUMS WERE INFLAMED. SITE WAS GRAFTED FOR FUTURE IMPLANT . NOTED INFLAMMATION.

  Patient problems: Hypersensitivity/Allergic reaction; Osteolysis; Unspecified Infection

  MAUDE report 25204243 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #35 AND #37 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25184012 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA TELEPHONE THAT THE IMPLANT AT TOOTH SITE #7 WAS REMOVED DUE TO INFECTION AND BONE LOSS. NO MEDICAL HISTORY WAS AVAILABLE. THE PATIENT ANTICIPATED RETURNING FOR AN IMPLANT REPLACEMENT ONCE THE SITE HEALS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24802138 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 12 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 24727753 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. INFECTION, LOOSENING ALSO REPORTED. TOOTH NUMBER10. IMPLANT PLACED USING SURGICAL GUIDE. GREATER THAN 35 N-CM ACHIEVED ON INITIAL INSERTION. PATIENT FOLLOWED UP TWO MONTHS LATER WITH PAIN AND SWELLING AT AREA. IMPLANT TO BE REPLACED. SYMPTOMS / PATIENT IMPACT: EDEMA, INFLAMMATION, PAIN, SWELLING.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24706934 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24233201 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS REMOVED DUE TO BONE LOSS IN (B)(6) 2025. THIS WAS NOTICED BY THE GENERAL DENTIST PRIOR TO AN APPOINTMENT TO UNCOVER THE TOOTH SITE. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO RETREAT THE AREA.

  Patient problems: Osteolysis

  MAUDE report 24100753 ↗
• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #21, #23, AND #27 WERE REMOVED DUE TO INFECTION. PATIENT PRESENTED WITH PAIN, AND SWELLING. SYMPTOMS AS A RESULT OF THE EVENT WAS ABSCESS.

  Patient problems: Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 23858506 ↗
• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #21, #23, AND #27 WERE REMOVED DUE TO INFECTION. PATIENT PRESENTED WITH PAIN, AND SWELLING. SYMPTOMS AS A RESULT OF THE EVENT WAS ABSCESS.

  Patient problems: Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 23858504 ↗
• InjuryNov 18, 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: Unspecified Infection

  MAUDE report 23587413 ↗
• InjuryNov 11, 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 #10 GOT INFECTED AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS; PAIN & SWELLING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23523693 ↗
• InjuryNov 6, 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 #5 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 23490800 ↗
• InjuryNov 6, 2025Adverse 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: Sinus Perforation

  MAUDE report 23485434 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS NO IMPROVEMENT AROUND THE IMPLANT AREA OF NON-HEALING BONE IN THE APICAL REGION OF THE IMPLANT AT TOOTH SITE #21. THE HEALING ABUTMENT WAS REMOVED. A FULL THICKNESS FLAP WITH AN ANTERIOR VERTICAL RELEASE WAS REFLECTED. THE IMPLANT WAS REMOVED USING REVERSE TORQUE. THE OSTEOTOMY WAS SMOOTHED, CURETTED, AND IRRIGATED. DECORTICATED. THERE WAS A NARROW 8MM DEHISCENCE OF BUCCAL BONE NOTED.

  Patient problems: Osteolysis

  MAUDE report 23429593 ↗