NANOTITE™CERTAIN®PREVAIL® NIITP6510Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868011026), received between Oct 23, 2020 and Jun 4, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 11942770 ↗
• InjuryJun 4, 2021Adverse 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: Inflammation; Unspecified Infection

  MAUDE report 11941773 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE NIITP6510 IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS ALSO REPORTED. TOOTH LOCATION #16.

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10726552 ↗