OSSEOTITE® CERTAIN® XIFNT613Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00844868022077), received between Apr 2, 2020 and Jul 7, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 16/25/36/UNKNOWN/UNKNOWN WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22411248 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 16, 15, 26 WERE REMOVED DUE TO SEVERE PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21983115 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PT. HAD PAIN W IMPLANT. REMOVAL OF IMPLANT DUE TO PAIN. TOOTH #30 (UNIVERSAL).

  Patient problems: Pain

  MAUDE report 19701916 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PATIENT WAS EXPERIENCING PAIN AND NUMBNESS, WHICH WAS NOT SETTING BETTER. IMPLANT WAS HAVING SIGNIFICANT/ADVANCE BONE LOSS IN THE AREA. AND IMPLANT WAS REMOVED. TOOTH 19. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA, INFLAMMATION.

  Patient problems: Osteolysis; Pain

  MAUDE report 17646102 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PERI-IMPLANTITIS AT SITE #18. IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17613315 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 30 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS: PAIN. SITE GRAFTED: ALLOGRAFT PRIOR TO IMPLANT PLACEMENT ON (B)(6) 2019.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 15412252 ↗
• InjuryFeb 11, 2021Adverse 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. SITE GRAFTED. PATIENT NOT RETURNING FOR IMPLANT RE-PLACEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 11316347 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANT SITE THAT REQUIRED REMOVAL OF THE IMPLANT. IT WAS NOT INDICATED IF THE PATIENT WOULD RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #30.

  Patient problems: Unspecified Infection

  MAUDE report 10727983 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE IMPLANT WAS UNABLE TO BE PLACED AS THE BONE WAS NOT STRONG ENOUGH THEREFORE THEY REMOVED THE IMPLANT AND GRAFTED THE SITE. PATIENT WILL RETURN AFTER THE BONE HEALS. TOOTH #30.

  Patient problems: No Information

  MAUDE report 10448304 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THEY WERE NOT ABLE TO ACHIEVE PRIMARY STABILITY WITH IMPLANT XIFNT613 IN TOOTH SITE #19.

  Patient problems: No Information

  MAUDE report 10200506 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PRIMARY STABILITY WAS NOT ACHIEVED WITH IMPLANT XIFNT613 IN TOOTH SITE # 19.

  Patient problems: No Information

  MAUDE report 9917346 ↗