NANOTITE™ CERTAIN® NINT410Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844868011125), received between Sep 17, 2019 and Jul 23, 2021 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2021Adverse 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 INFECTION. TOOTH LOCATION 23. SWELLING AND INFLAMMATION WERE ALSO REPORTED.

  Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 12220944 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR INDICATED INFECTION. THE MUCOSA AROUND THE IMPLANT AT TOOTH SITE #21 WAS RED AND SWOLLEN, LEADING TO THE IMPLANT FAILURE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 12211293 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PERI-IMPLANTITIS WITH INFECTION, LOSS OF INTEGRATION, AN ABSCESS, PAIN AND EDEMA PRESENT. IMPLANT WAS REMOVED AND PATIENT WILL RETURN FOR A REPLACEMENT IMPLANT IN THE FUTURE. TOOTH #19.

  Patient problems: Abscess; Inadequate Osseointegration; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 11337805 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE NINT410 IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. TOOTH LOCATION # 29. THE SITE WAS GRAFTED WITH XENOGRAFT PRIOR TO ORIGINAL PLACEMENT. PAIN IS ALSO REPORTED.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 11193929 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED PERI-IMPLANTITIS AFTER THE IMPLANTATION. PATENT PRESENTED WITH INFLAMMATION AND EDEMA.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 11138918 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE IMPLANT HAD TO BE REMOVED DUE TO PERI-IMPLANTITIS, INFLAMMATION, EDEMA AND A LOSS OF INTEGRATION. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS.

  Patient problems: Edema; Inflammation; No Code Available; Unspecified Infection

  MAUDE report 11127160 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION AT TOOTH LOCATION 21. THE MUCOSA AROUND THE IMPLANT WAS RED AND SWOLLEN, CAUSING IMPLANT FAILURE. PATIENT EXHIBITED INFLAMMATION AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 10279803 ↗
• InjurySep 17, 2019Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 9075057 ↗