NANOTITE™ CERTAIN® NINT585Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844868011217), received between Oct 2, 2020 and Oct 22, 2021 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration; Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 12682412 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 7 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. PER INDICATED: THE IMPLANT WAS PLACED IN THE PATIENT ON (B)(6) 2019, AND THERE WERE NO ADVERSE REACTIONS AFTER PLACEMENT. THREE MONTHS LATER, THE PATIENT REPORTED IMPLANT LOOSENESS, AND PERI-IMPLANTITIS WAS FOUND THROUGH EXAMINATION, SO THE IMPLANT WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED: NONE REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10621498 ↗
• InjuryOct 2, 2020Adverse 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 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. PER INDICATED: THE IMPLANT WAS PLACED IN THE PATIENT ON (B)(6) 2019, AND THERE WERE NO ADVERSE REACTIONS AFTER PLACEMENT. THREE MONTHS LATER, THE PATIENT REPORTED IMPLANT LOOSENESS, AND PERI-IMPLANTITIS WAS FOUND THROUGH EXAMINATION, SO THE IMPLANT WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED: NONE REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10621379 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # UL7 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. PER INDICATED: THE IMPLANT WAS PLACED IN THE PATIENT ON (B)(6) 2019, AND THERE WERE NO ADVERSE REACTIONS AFTER PLACEMENT. THREE MONTHS LATER, THE PATIENT REPORTED IMPLANT LOOSENESS, AND PERI-IMPLANTITIS WAS FOUND THROUGH EXAMINATION, SO THE IMPLANT WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED: NONE REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10620545 ↗