OSSEOTITE® CERTAIN® 2 XIFOSM310Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00844868023081), received between Jan 31, 2020 and Jan 15, 2026 — classified as 9 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 9 most recent of 9 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 THE IMPLANT AT TOOTH SITE #25 WAS REMOVED DUE TO PERI-IMPLANTITIS. BONE REGENERATION WAS PERFORMED. ANOTHER IMPLANT WILL BE PLACED LATER.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24084469 ↗
• InjuryApr 16, 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: Pain

  MAUDE report 19119312 ↗
• InjuryApr 16, 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: Pain

  MAUDE report 19119016 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #28, WITH ASSOCIATED ABSCESS. PATIENT STILL HAD PAIN AND SWELLING, AND X-RAY WAS TAKEN; THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 18244796 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH BONE LOSS AROUND THE IMPLANT AT TOOTH LOCATION #6 AND THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 16467454 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #4 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15599474 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION WITH PAIN/SWELLING AND PURULENCE AT APEX #13 W/BUCCAL CORTICAL PERFORATION, AND GRANULATED TISSUE. THE INFECTION/PAIN THAT WAS PRESENT HAS SINCE BEEN RESOLVED AFTER THE REMOVAL OF THE IMPLANT. SITE WAS DEBRIDED AND ANTIBIOTICS WERE PRESCRIBED. NO ADDITIONAL MEDICAL INTERVENTION NECESSARY. AN ABSCESS, PAIN, INFLAMMATION, AND EDEMA WERE REPORTED SYMPTOMS.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 14253080 ↗
• InjuryFeb 21, 2020Adverse 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 25.

  Patient problems: Unspecified Infection

  MAUDE report 9739125 ↗
• InjuryJan 31, 2020Adverse 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. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 9655683 ↗