OSSEOTITE® CERTAIN® PREVAIL XIITP4315Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00844868022145), received between Nov 5, 2019 and Jun 4, 2026 — classified as 27 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO (2) IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PATIENT WILL RETURN TO HAVE IMPLANTS REPLACED. TOOTH LOCATIONS WERE NOT PROVIDED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25399370 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. MOBILE. FAILED. TOOTH NUMBER 3.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25105474 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TOOTH #8 WAS EXTRACTED AND AN IMMEDIATE SINGLE-PHASE IMPLANT WAS PLACED AT THE SITE WITH BONE GRAFTING AND EXCELLENT PRIMARY STABILITY. THE PATIENT RETURNED THREE (3) AND 1/2 WEEKS LATER WITH A LOOSE IMPLANT. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24927130 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #7 WAS PLACED IMMEDIATELY AFTER THE EXTRACTION OF ANOTHER IMPLANT. EXCELLENT PARING AND STABILITY WAS NOTED AND A TEMPORARY BRIDGE WAS PLACED. THE PATIENT DEVELOPED GINGIVAL SWELLING THREE MONTHS LATER AND THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 24562561 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #25 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24521278 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24028660 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #25 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23098141 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #14 WAS MOBILE AND WAS REMOVED DUE TO PERIIMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22983007 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. PAIN AND SWELLING AT IMPLANT SITE 22. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22062844 ↗
• InjuryMay 8, 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 #3, #5, #7, #9, #12, #13 AND #14 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21983715 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #24 WAS MOBILE AND FAILED DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21282041 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE NUMBER 22 FAILED, DUE TO BONE LOSS & INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20138112 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE NUMBER 30 FAILED, DUE TO BONE LOSS & INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20138074 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSSS.

  Patient problems: Osteolysis

  MAUDE report 19742671 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 19742603 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19132484 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 18437188 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPON TAKING POST OPERATIVE X-RAYS IT WAS NOTICED THERE WAS BONE LOSS AROUND IMPLANT AT TOOTH SITE #22. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 17954824 ↗
• InjuryAug 10, 2023Adverse 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 #10. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Unspecified Infection

  MAUDE report 17497958 ↗
• InjuryOct 24, 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 #24 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15657712 ↗
• InjuryJun 3, 2022Adverse 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 PAIN AT THE IMPLANT SITE.

  Patient problems: Pain

  MAUDE report 14594855 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT BECAME INFECTED AT ABOUT TWO WEEKS AFTER PLACEMENT, AND WAS REMOVED. TOOTH SITE # 11.

  Patient problems: Unspecified Infection

  MAUDE report 13529628 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE XIITP4315 IMPLANT DID NOT ACHIEVE PRIMARY STABILITY. TOOTH LOCATION #9. THE SITE WAS GRAFTED WITH XENOGRAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871787 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PATIENT RETURNED WITH PAIN AND INFECTION SO THE XIITP4315 IMPLANT AT TOOTH SITE #29 WAS REMOVED AND SITE GRAFTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11391701 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED INFECTION AND SINUSITIS, THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 10464342 ↗