T3 T3ST3285Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00844868046905), received between Oct 9, 2023 and May 12, 2026 — classified as 11 injuries.

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.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT UNCOVERY, THE IMPLANT WAS FOUND TO HAVE SEVERE BONE LOSS. IMPLANT WAS REMOVED AND WILL RETURN TO PLACE A NEW IMPLANT AFTER BONE GRAFT HEALS. NOTED INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 25153414 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT REPORTED PAIN AND MOBILITY OF THE IMPLANT CROWN AT TOOTH SITE #9. BONE LOSS WAS NOTED AROUND THE IMPLANT, AND THE IMPLANT WAS PLANNED TO BE SURGICALLY REMOVED. HOWEVER, THE IMPLANT FELL OUT ON ITS OWN.

  Patient problems: Osteolysis; Pain

  MAUDE report 25102313 ↗
• 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.VED.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 24661200 ↗
• 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 #5 WAS PLACED FOR OVERDENTURE AND FAILED SHORTLY AFTER USING. THE IMPLANT WAS REMOVED DUE TO BONE LOSS & INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23015563 ↗
• InjuryMar 27, 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 #6 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21710187 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO PERI-IMPLANTITIS. REPORTED PAIN AS CONSEQUENCE OF THE EVENT. TOOTH LOCATION 25.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21503939 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BONE LOSS WAS NOTED AROUND THE IMPLANTS AT TOOTH LOCATIONS #11, #19 AND #20 DURING GINGIVAL FLAP EVALUATION. THE DECISION WAS MADE TO REMOVE THE IMPLANTS.

  Patient problems: Osteolysis

  MAUDE report 20039065 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE # 13 WAS REMOVED AND ALLOGRAFT PLACED DUE TO BONE LOSS AND POOR STABILITY.

  Patient problems: Osteolysis

  MAUDE report 19510292 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE #20 (FDI) DID NOT HEAL PROPERLY AND WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18530364 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGICAL UNCOVERING, AFTER POST OP CBCT IMPLANT WAS NOTED WITH BONE LOSS. TOOTH #30. THE IMPLANT WAS REMOVED. GRAFTED WITH ALLOGRAFT WITH ORIGINAL PLACEMENT AND AT REMOVAL.

  Patient problems: Osteolysis

  MAUDE report 18408708 ↗
• InjuryOct 9, 2023Adverse 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: Pain

  MAUDE report 17893487 ↗