OSSEOTITE® CERTAIN® 2 XIFOSS585Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844868023258), received between Nov 22, 2019 and Aug 5, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT IMPLANT DEFECTIVE WHEN PLACING IT INTO THE PATIENT'S MOUTH. DR. USED ANOTHER IMPLANT (SAME SIZE) AND IT WAS SUCCESSFULLY ABLE TO BE PLACED ON THE SAME DAY. DR. THINKS SOMETHING IS WRONG WITH THE HEX, BUT HE'S NOT 100% SURE. TOOTH #31.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905982 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT TOOTH SITE # 19 AFTER PLACEMENT OF IMPLANT. THE IMPLANT WAS REMOVED AND THE SITE ALLOGRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Abscess; Inflammation; Pain; Unspecified Infection

  MAUDE report 17130990 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #(B)(6) WAS REMOVED DUE TO SIGNIFICANT DISTAL BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 17050706 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED DUE TO LACK OF PRIMARY STABILITY. THE IMPLANT WAS LOOSE AT THE TIME OF PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591034 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT HAD INFECTION AT THE IMPLANT SITE THAT REQUIRED THE IMPLANT TO BE REMOVED. PROCEDURE WAS NOT COMPLETED USING ANOTHER IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 11981670 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS UNABLE TO PLACE THE IMPLANT INTO THE PATIENT'S OSTEOTOMY.

  Patient problems: No Information

  MAUDE report 9363058 ↗