T3 T3PT4385Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00844868046752), received between Nov 24, 2023 and Sep 28, 2026 — classified as 31 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

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

  It was reported that when switching the cover screw for an encode healing abutment for implants #19,20, fair amount of granulation tissue was noticed in both implants and they were loose as well. Implant had to be removed due to periimplantitis. This event refers to the peri-implantitis in tooth site 20.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50914311 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS PLACED, AND AFTER THE PROSTHETIC RESTORATION, ABOUT A YEAR LATER, THE IMPLANT CAME OUT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24834863 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS AT TOOTH SITES #46-47. DURING INSERTION THE BONE WAS VERY DENSE AND NARROW, AND PLASMA WAS USED. AT 50 NCM THE PATIENT EXPERIENCED POSTOPERATIVE DISCOMFORT AND WAS PLACED ON ANTIBIOTICS FOR 7 DAYS. DUE TO THE INFLAMMATION AND PAIN, REMOVAL WAS DECIDED. IMPLANTS WERE REMOVED.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 24661124 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 5 IMPLANTS WERE PLACED IN OCT 2025. DURING SECOND SURGERY IN JANUARY TOOTH LOCATION #46 AND #36 HAD MOBILITY AND #36 HAD SUPPURATION. IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24388544 ↗
• InjuryDec 22, 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 #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED BY PLACING ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23869327 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN THE CLINIC FOR AN X-RAY AND FINAL CHECK OF THE IMPLANT AT TOOTH SITE #29. THE X-RAY SHOWED INFECTION SO THE PATIENT STAYED FOR REMOVAL. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 23487245 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS INFECTED AND REMOVED. TOOTH SITE: 20. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 23379556 ↗
• InjuryOct 23, 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 SINUS PERFORATION. A SINUS LIFT WAS PERFORMED DURING IMPLANT PLACEMENT. AFTER A COUPLE OF DAYS, THE PATIENT STARTED TO FEEL A LITTLE BLEEDING THROUGH THE NOSE, BUT IT STOPPED. AT THE TIME OF THE IMPLANT UNCOVERING, THE IMPLANT COULDN'T BE LOCATED. X-RAY IMAGING CONFIRMED THAT THE IMPLANT HAD MOVED INSIDE THE SINUS CAVITY. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT IF THE SINUS PERFORATION HEALED. SYMPTOMS AS A RESULT OF THE EVENT: BLEEDING THROUGH THE NOSTRIL AND WATER.

  Patient problems: Sinus Perforation

  MAUDE report 23368952 ↗
• InjuryOct 22, 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: Inflammation; Unspecified Infection

  MAUDE report 23359517 ↗
• InjurySep 16, 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 #14 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 23061737 ↗
• InjuryAug 29, 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 # 13 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT WERE ABSCESS, INFLAMMATION, AND SWELLING.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 22924773 ↗
• InjuryAug 27, 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: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22906845 ↗
• InjuryJun 19, 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 #4 AND #11 WERE REMOVED DUE TO PERI-IMPLANTITIS. ABNORMAL BONE TO IMPLANT CONTACT AT #4 AND #11 WITH PERI-IMPLANT RADIOLUCENCY SEEN ON BOTH #4 AND #11 DEPRESSIBLE FAILED TO INTEGRATE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22289785 ↗
• MalfunctionMay 15, 2025Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026990 ↗
• InjuryApr 26, 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 #21 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 21915352 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 47 WAS REMOVED DUE TO PERI-IMPLANTITIS .PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT. DOCTOR ALSO INDICATED A DELAY IN THE PROCEDURE OF 8 WEEKS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21650620 ↗
• InjuryFeb 4, 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: Nerve Damage; Pain; Paresthesia

  MAUDE report 21308032 ↗
• 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: Discomfort; Sinus Perforation

  MAUDE report 21294415 ↗
• InjuryJan 31, 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 #13 WAS REMOVED DUE TO BONE LOSS AROUND THE IMPLANT. THIS WAS NOTED DURING ROUTINE X-RAYS TAKEN BY THE GENERAL DENTIST. A BONE GRAFT IN THE SOCKET WAS PERFORMED WITH THE REPLACEMENT EXPECTED WITHIN 2 OR THREE MONTHS.

  Patient problems: Osteolysis

  MAUDE report 21283704 ↗
• InjuryNov 18, 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; Pain; Paresthesia

  MAUDE report 20704003 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SITES 12 AND 13 HAS AN ALLERGIC REACTION 7 MONTHS POST OP. NOTED PAINSITE GRAFTED WITH ALLOGRAFT.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 20358556 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SITES 12 AND 13 HAS AN ALLERGIC REACTION 7 MONTHS POST OP. NOTED PAIN SITE GRAFTED WITH ALLOGRAFT.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 20358461 ↗
• InjurySep 23, 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 # UNK WAS REMOVED DUE TO BONE LOSS. PATIENT RETURNED ALMOST 1 YEAR AFTER PLACEMENT WITH SEVERE LOSS OF INTEGRATION.

  Patient problems: Osteolysis

  MAUDE report 20283098 ↗
• InjurySep 5, 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: Inflammation; Osteolysis

  MAUDE report 20146480 ↗
• InjurySep 5, 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: Inflammation; Osteolysis

  MAUDE report 20146290 ↗