T3 T3PT4311Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00844868046721), received between Oct 7, 2022 and Sep 17, 2026 — classified as 72 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that two implants at tooth sites 27 and 30 were removed due to a large bone loss and an infection.Sites were grafted and patient will return in 4 months to place a new implants.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50799147 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to infection and bone loss. at tooth site 20.New implant will be placed in 3 months.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50798987 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported implant was removed due to infection and bone loss.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50302129 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  The implant at tooth #5 was removed due to infection, bone loss, and fistula formation despite antibiotics and debridement. An abscess and inflammation were also noted.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50299186 ↗
• InjuryJun 12, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE # 30 WAS REMOVED DUE TO INFECTION & BONE LOSS AND ALLERGIC REACTION. POSSIBLE ALLERGIC REACTION OR PATIENT'S BODY REJECTING IMPLANTS. POST-OP VISIT 2 FOR ZIMVIE BIOMET 3I DENTAL IMPLANT 29 T3PT4310 TIGHT TO 50 NCM AND ENCODE HEALING ABUTMENT IEEHA353. PATIENT DOING WELL AND USED MEDICATIONS (CEFDINIR) AS PRESCRIBED. MILD REDNESS 31-M BUT NO GINGIVAL SWELLING. BOTH HEALING ABUTMENTS MOBILE AND PAIN TO TWISTING. PERIAPICAL RADIOGRAPH LR AND SHOWS RADIOLUCENCY ALL AROUND THE DENTAL IMPLANT. APPEARS PATIENT REJECTING THE DENTAL IMPLANT OR COULD HAVE HAD AN INFECTION. PATIENT HAS TITANIUM JOINT REPLACEMENTS WITH NO PROBLEMS. SHE KNOWS OF NO METAL ALLERGIES. EXPLAINED TO PATIENT DENTAL IMPLANT NEEDS TO BE REMOVED AND BONE GRAFTING OF THE RIDGE NEEDED AGAIN. I SHOWED PATIENT THE POST-OP RADIOGRAPH ON (B)(6) 2026 AND HOW GOOD THE BONE LOOKED AND HOW IT HAS RESORBED SINCE THEN. SYMPTOMS / PATIENT IMPACT: PAIN, SWELLING.

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

  MAUDE report 25484808 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DENTAL IMPLANT WAS PLACED AND THE SURGICAL TOOTH SITE #15 WAS COMPLETELY SUTURED CLOSED. HOWEVER, AN INFECTION SUBSEQUENTLY DEVELOPED, LEADING TO RESORPTION OF THE LABIAL/BUCCAL BONE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25305802 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 25092868 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 25059167 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # (B)(6) WAS REMOVED DUE TO A LOSS OF INTEGRATION ASSOCIATED WITH PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24836141 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #7 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 24757250 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #11 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. IT WAS NOTED THAT THE IMPLANT BECAME TENDER AND MOBILE A YEAR AFTER SUPPORTING AN OVER-DENTURE. IT WAS REPORTED THAT THE PATIENT HAD FIVE OTHER IMPLANTS TO SUPPORT THE OVER-DENTURE. THE SIXTH IMPLANT DID NOT NEED TO BE REPLACED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24031451 ↗
• InjuryDec 19, 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; Pain

  MAUDE report 23854411 ↗
• InjuryDec 18, 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: Nerve Damage; Pain; Paresthesia

  MAUDE report 23837350 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S ADJACENT TOOTH TO THE IMPLANT AT TOOTH SITE #13 WAS INFECTED AND CAUSED THE IMPLANT TO FAIL. THE IMPLANT WAS REMOVED DUE TO THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23826507 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 47 WAS REMOVED DUE TO PARESTHESIA. EXTRACTION OF TOOTH 47 WITH IMMEDIATE IMPLANT PLACEMENT. THE EXTRACTION WAS PAINFUL, AND A CYST WAS PRESENT NEAR THE ALVEOLAR NERVE. THE IMPLANT WAS PLACED, AND DURING THE PATIENT¿S EVENING CALL NO PAIN WAS REPORTED. THE FOLLOWING DAY, THE PATIENT CALLED COMPLAINING OF ALTERED NERVE SENSATION. A HEMATOMA WAS IDENTIFIED BETWEEN THE IMPLANT AND THE NERVE. THE IMPLANT WAS REMOVED. ON THE SCAN, THE HEMATOMA APPEARED STABLE. PROCEDURE WAS NOT COMPLETED.

  Patient problems: Cyst(s); Hematoma; Paresthesia

  MAUDE report 23725627 ↗
• InjuryOct 15, 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; Unspecified Infection

  MAUDE report 23306472 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED BONE LOSS ON TOOTH SITE #4. THE IMPLANT FAILED. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REPLACE THE IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 23306291 ↗
• InjuryOct 15, 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; Unspecified Infection

  MAUDE report 23301516 ↗
• InjurySep 10, 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. ON (B)(6) 2025 - SHE REPORTS A TIGHTNESS IN HER GUMS WHEN SHE OPENS WIDE. SHE ALSO REPORTS THAT WHEN SHE PUSHES ON THE APEX OF THE IMPLANT SHE TASTES SALT. SHE NOTED REDNESS AROUND THE IMPLANT. THERE IS BONE LOSS ALONG THE AXIAL OF THE IMPLANT AT SITE #13. ON (B)(6) 2025 - #13- THE IMPLANT WAS REMOVED USING REVERSE TORQUE. THERE WAS COMPLETE DEHISCENCE OF THE BUCCAL PLATE. ALL OTHER BONY WALLS AND SINUS MEMBRANE WERE NOTED TO BE INTACT. CO/CA/XE REGENEROSS BONE WAS MIXED WITH PRF EXUDATE AND USED TO GRAFT THE EXTRACTION SITE. A PRF MEMBRANE WAS PLACED OVERLYING THE BUCCAL DEFECT. A PRF MEMBRANE WAS PLACED OVERLYING THE GRAFT AND SECURED WITH 3-0 CHROMIC SUTURE. SYMPTOMS AS A RESULT OF THE EVENT: SALTY TASTE AND REDNESS AROUND ABUTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis

  MAUDE report 23018783 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR CROWN READINESS AND IT WAS FOUND THAT THE IMPLANT AT TOOTH SITE #11 NEEDED TO COME OUT DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 22953330 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEBRIDEMENT OF THE IMPLANT AT TOOTH SITE #12 EXPOSED A FAILED IMPLANT. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22942018 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE #30 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT WERE PAIN, AND SWELLING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22906769 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT AN UNKNOWN TOOTH SITE WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT WERE INFLAMMATION, PAIN, AND SWELLING.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 22865294 ↗
• InjuryAug 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 #12 WAS REMOVED USING REVERSE TORQUE DUE TO BONE LOSS. A FULL THICKNESS FLAP WAS REFLECTED. THE OSTEOTOMY WAS DEBRIDED OF ALL SOFT TISSUE DOWN TO HEALTHY BONE. THERE WAS A BUCCAL FENESTRATION NOTED. ALL 4 BONY WALLS AND THE SINUS FLOOR WERE NOTED TO BE INTACT. DECORTICATED. CO/CA/XE REGENEROSS BONE MIXED WITH PRF EXUDATE WAS USED TO GRAFT THE OSTEOTOMY. A PRF MEMBRANE WAS PLACED. SOFT TISSUES WERE REAPPROXIMATED USING 3-0 GUT SUTURE.

  Patient problems: Osteolysis

  MAUDE report 22823077 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED CEFTIN AND MEDROL ANTIBIOTICS DOSE PACKS TO RESOLVE TENDERNESS ASSOCIATED WITH IMPLANTS AT TOOTH SITES #19 AND #20. THE IMPLANTS WERE NOTED TO BE STABLE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain

  MAUDE report 22589447 ↗