3i T3® BOPS5410Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868028437), received between Jul 17, 2021 and Dec 7, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2024Adverse 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 PERI-IMPLANTITIS AT TOOTH LOCATION 36. SITE WAS SURGICAL DESINFECTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20873611 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INCREASING PAIN STARTED AROUND THE IMPLANT AT TOOTH LOCATION #29 ONE (1) WEEK AFTER IMPLANT PLACEMENT. THE IMPLANT WAS REMOVED.

  Patient problems: Pain

  MAUDE report 20371838 ↗
• InjuryNov 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 FRACTURED AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233234 ↗
• InjuryJul 11, 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: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 17298339 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO INFECTION & BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 15820196 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO OBSERVE THE STATUS OF THEIR HEALING FOLLOWING IMPLANT PLACEMENT AND THE PATIENT COMPLAINED OF CONSTANT PAIN AND INFLAMMATION IN THE AREA OF THE IMPLANT. INFECTION WAS NOTED. AFTER A COURSE OF ANTIBIOTICS AND A RADIOGRAPH OF THE AREA, REMOVAL WAS NECESSARY. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 12519115 ↗
• InjuryJul 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE #3 WAS UNABLE TO PLACE DUE TO LACK OF PRIMARY STABILITY, AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186138 ↗