OSSEOTITE® CERTAIN® XIFNT685Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868022091), received between Jul 16, 2020 and Jan 15, 2026 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #14 AND ON THE DAY OF REMOVAL, THE IMPLANT CAME OUT EASILY WITH THE CROWN STILL ATTACHED.

  Patient problems: Osteolysis

  MAUDE report 24081422 ↗
• InjuryDec 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis

  MAUDE report 20875046 ↗
• InjuryJul 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BECOMING FRACTURED AND BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 15130092 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT PATIENT NOTED INFLAMMATION IN GUM TISSUE. IMPLANT AT TOOTH SITE #14 (UNIVERSAL) LOST INTEGRATION DUE TO PERI-IMPLANTITIS. IMPLANT WAS REMOVED AND AREA WAS GRAFTED WITH ALLOGRAFT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 12505361 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE CUSTOMER CONFIRMING THIS EVENT AS NON-INTEGRATION. CLARIFICATION WAS RECEIVED CONFIRMING THAT NON COMPLICATION WERE FOUND AFTER IMPLANT PLACEMENT. ONE WEEK LATER IMPLANT FELT LOOSE AND IT FAILED TO INTEGRATE. IRRITATION WAS NOTED. TOOTH LOCATION 20. AS A RESULT, EVENT HAS BEEN REASSESSED.

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

  MAUDE report 10285979 ↗