OSSEOTITE® CERTAIN® PREVAIL XIITP6585Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00844868022244), received between May 25, 2021 and Jun 11, 2026 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED REGARDING SEVERE BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #31. THE DENTIST WAS NOT COMFORTABLE RESTORING THE IMPLANT WITH SUCH BONE LOSS. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED.

  Patient problems: Osteolysis

  MAUDE report 25476691 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS REQUIRED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24192550 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24167749 ↗
• InjuryDec 18, 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 ASSOCIATED WITH THE SINUSES AND CAUSED LOSS OF INTEGRATION. TOOTH SITE: 14.

  Patient problems: Unspecified Infection

  MAUDE report 23838991 ↗
• InjuryMar 17, 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 #30 WAS REMOVED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21618281 ↗
• InjuryFeb 13, 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 #3 WAS REMOVED DUE TO PERI IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21378679 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING SEVERE PAIN WITH THE IMPLANT AT TOOTH LOCATION #14 AND DEMANDED IT BE REMOVED.

  Patient problems: Pain

  MAUDE report 20759481 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS. IMPLANT MOBILE, IT FAILED AND HAD AN ABSCESS, ON TOOTH #29. PER INDICATED: SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THERE A DELAY DURING THE PROCEDURE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES, NEW IMPLANT, BONE GRAFT. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20693703 ↗
• InjuryMar 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #19, WITH ASSOCIATED. THEREFORE, THE IMPLANT WAS MOBILE, FAILED AND WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18919074 ↗
• MalfunctionAug 24, 2023Mechanical Problem; Mechanical Problem

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

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

  MAUDE report 17610700 ↗
• InjuryJun 14, 2023Adverse 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 PERI-IMPLANTITIS. THE BONE WAS GRAFTED FOR IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17126424 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. SYMPTOMATIC. PAINFUL. PATIENT REQUESTED REMOVAL.ADDITIONAL APPOINTMENT REQUIRED FOR NEW IMPLANT, BONE GRAFT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 16952936 ↗
• InjuryJan 25, 2023Adverse 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: Sinus Perforation

  MAUDE report 16240883 ↗
• InjuryJan 25, 2023Adverse 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: Sinus Perforation

  MAUDE report 16240798 ↗
• InjuryNov 29, 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 #3 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 15883383 ↗
• MalfunctionMay 24, 2022Mechanical Problem; Mechanical Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Failure of Implant

  MAUDE report 14492760 ↗
• InjuryMay 17, 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 THAT OCCURRED AFTER THE PATIENT STATED SHE FELL IN (B)(6) 2022, BROKE HER WRIST AND CROWNS ON IMPLANTS. PATIENT REPORTS THAT SINCE HER FALL, PAIN HAS BECOME PROGRESSIVELY WORSE AND SHE WAS UNABLE TO BITE DOWN. BRIDGE MOBILE.

  Patient problems: Pain

  MAUDE report 14414375 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND INFECTION/PERI-IMPLANTITIS AT TOOTH LOCATION #15. THE CROWN WAS REMOVED BY THEIR DENTIST, THEN THE IMPLANT WAS REMOVED W/MINIMAL REVERSE TORQUE 10 NCM. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 13791385 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT PLACED DURING A SIMULTANEOUSLY VERTICAL SINUS LIFT SURGERY. THE IMPLANT WAS OSSEOINTEGRATED , BUT 3 MONTHS AFTER RESTORATION THERE WAS BONE LOSS, MOBILITY AND PERI-IMPLANTITIS AND THEREFORE THE IMPLANT WAS REMOVED. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13590006 ↗
• InjurySep 24, 2021Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #S13 & 14 LOST INTEGRATION DUE TO PERI-IMPLANTITIS/INFECTION AT THE IMPLANT SITES AND WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 12526172 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12142085 ↗
• InjuryMay 25, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT INTERNAL HEX STRIPPED ON IMPLANT AT SITE # 14. IMPLANT REMOVED. ADDITIONAL APPOINTMENTS / IMPLANT RE-PLACEMENT: NOT INDICATED. AS A RESULT OF THE EVENT NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11877357 ↗