NANOTITE™CERTAIN®PREVAIL® NIITP5411Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868010982), received between Mar 23, 2020 and Sep 24, 2020 — 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.

• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL PATIENTS PERIO MAINTENANCE VISITS AND X-RAYS DEMONSTRATED INCREASE IN POCKET DEPTHS AND ACTIVITY AROUND IMPLANT AT TOOTH LOCATION # 30. IMPLANT AT #30 WAS REMOVED DUE TO SEVER BONE LOSS. NO INJURY TO PATIENT OTHER THAN IMPLANT BEING REMOVED. NO PERMANENT IMPAIRMENT, DOES NOT STATE DELAY OR PATIENT RETURN DATE SYMPTOMS: BONE LOSS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10579374 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO UPDATE TO THE ORIGINAL DESCRIPTION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9865368 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO UPDATE TO THE ORIGINAL DESCRIPTION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9865196 ↗