OSSEOTITE® CERTAIN® PREVAIL XIITP6515Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00844868022237), received between Nov 22, 2019 and Jun 23, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Problem with Removal of Enzymatic Cleaner” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 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 #47 AND #37 WERE REMOVED DUE TO ALLERGIC REACTION AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Unspecified Infection

  MAUDE report 22306692 ↗
• InjurySep 27, 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 #19 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20322790 ↗
• InjuryJun 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 #12, 14, 15 WERE REMOVED DUE TO PERI IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19462009 ↗
• InjuryJun 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 #12, 14, 15 WERE REMOVED DUE TO PERI IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19461896 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED BONE LOSS AT TOOTH SITE # 14 AND THE IMPLANT WAS REMOVED AND SITE GRAFTED.

  Patient problems: Osteolysis

  MAUDE report 18977590 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED TO OFFICE STATING IMPLANT PLACED CAUSING RINGING IN HIS EARS. REMOVED AND GRAFTED PATIENT WILL RETURN IN 6 MONTHS FOR CBCT. TOOTH 8. SYMPTOMS AS A RESULT OF THE EVENT: OTHER: RINGING IN HIS EARS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15699176 ↗
• InjuryOct 31, 2021Problem with Removal of Enzymatic Cleaner; Problem with Removal of Enzymatic Cleaner

  IT WAS REPORTED THAT PRIMARY STABILITY COULD NOT BE ACHIEVED WITH THE IMPLANT. TOOTH POSITION # 15.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725663 ↗
• InjuryNov 19, 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 AT TOOTH LOCATION 14. ABSCESS WAS ALSO NOTED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 10869526 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO ACHIEVE PRIMARY STABILITY. THE IMPLANT WAS REMOVED FROM TOOTH SITE 18 AND THE SITE WAS GRAFTED.

  Patient problems: No Information

  MAUDE report 9495617 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Information

  MAUDE report 9363134 ↗