OSSEOTITE® CERTAIN® PREVAIL XIITP4311Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 00844868022121), received between Sep 10, 2019 and Sep 15, 2026 — classified as 141 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (4 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 25 most recent of 142 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #7 was removed due to peri-implantitis with loss of osseointegration. The patient experienced pain, edema, and inflammation.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50768302 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO INFECTION. THE IMPLANT HAD BEEN PLACED IN 2022 WITH NO PARTICULAR PROBLEMS AND GOOD STABILITY. THE PATIENT RETURNED IN THE SUMMER OF 2025 WITH AN ABSCESS ON THE IMPLANT, ACCOMPANIED BY SUPPURATION AND MARKED MOBILITY. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 25233398 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24668300 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. MOBILE. FAILED. TOOTH NUMBER 9.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24661380 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER 24 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24605783 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. POST OP VISIT 1 MONTH AFTER IMPLANT PLACEMENT, ABSCESS, TENDERNESS, PUS WHEN PROBING. TOOTH # 27. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 24468186 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #20 AND #21 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 24461206 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. PERFECT SURGICAL PLACEMENT, SUNK IN BONE PERFECT, FLUSH, TIGHT, PATIENT RETURNED FOR GUM SWELLING, PA SHOWED INFECTION. IMPLANT MOBILITY THOUGHT OTHER IMPLANT SUCCEEDING, BUT 1 MONTH LATER MOBILITY. TOOTH NUMBER 20 SYMPTOMS AS A RESULT OF THE EVENT: EDEMA AND INFLAMMATION.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 24412578 ↗
• 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 24028918 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  UPON FOLLOW UP, ADDITIONAL INFORMATION WAS RECEIVED UPDATING THIS EVENT. THE IMPLANT WAS REMOVED DUE TO A SCREW FRACTURE WHICH CAUSED GUM TISSUE OVERGROWTH OVER THE IMPLANT AND IMPLANT REMOVAL. UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT RETURNED TO THE CLINIC FOR THE UNCOVER OF THE IMPLANT AT TOOTH SITE #20. THE PATIENT STATED THAT THE CROWN BROKE OFF AND GUM TISSUE GREW OVER THE IMPLANT. MAINLY THE RETENTION SCREW FRACTURED OFF INTO THE IMPLANT REQUIRING IMPLANT REMOVAL. BASED ON THIS NEW INFORMATION, THE IMPLANT WAS REMOVED DUE TO THE SCREW FRACTURE, NOT INFECTION. THEREFORE, THIS REPORT IS BEING SUBMITTED TO RETRACT THE INITIAL REPORT FOR THE IMPLANT, MFR REPORT NUMBER THAT WAS SUBMITTED ON JANUARY 7, 2026 AND HAS BEEN SUBMITTED VIA THE SCREW UNDER MFR REPORT NUMBER 0001038806-2026-00187 THAT WAS SUBMITTED ON JANUARY 12, 2026.

  Patient problems: Unspecified Infection

  MAUDE report 23989959 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO HAVE ABUTMENTS PLACED ON THE IMPLANTS AT TOOTH SITES #21 AND #23. IT WAS NOTED THAT THE TOOTH SITE #24 HAD CLASS THREE MOBILITY AND HAD A SINUS TRACT FROM THE APEX TO BETWEEN IMPLANTS #21 AND #23. THE IMPLANTS WERE REMOVED, AND THE ABUTMENTS WERE UNABLE TO BE REPLACED AS A RESULT. THE IMPLANTS REQUIRED REPLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 23529091 ↗
• InjurySep 3, 2025Adverse 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: Hypersensitivity/Allergic reaction; Inflammation; Unspecified Infection

  MAUDE report 22956413 ↗
• InjurySep 3, 2025Adverse 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: Hypersensitivity/Allergic reaction; Inflammation; Unspecified Infection

  MAUDE report 22955808 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANT AT TOOTH LOCATION #5 WAS PLACED, NO DENTIST WOULD RESTORE THE IMPLANT DUE TO BONE LOSS. BONE GRAFTING AND IRRIGATION AROUND THE IMPLANT WAS PERFORMED THREE (3) TIMES. HOWEVER, STILL AFTER A COUPLE OF MONTHS, THE PATIENT CAME BACK REPORTING BONE LOSS. PANORAMIC X-RAY WAS TAKEN TO CONFIRM THE FINDINGS. THE IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 22373092 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANT AT TOOTH LOCATION #5 WAS PLACED, NO DENTIST WOULD RESTORE THE IMPLANT DUE TO BONE LOSS. BONE GRAFTING AND IRRIGATION AROUND THE IMPLANT WAS PERFORMED THREE (3) TIMES AND THE PATIENT WAS RELEASED.

  Patient problems: Osteolysis

  MAUDE report 22372953 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANT AT TOOTH LOCATION #5 WAS PLACED, NO DENTIST WOULD RESTORE THE IMPLANT DUE TO BONE LOSS. BONE GRAFTING AND IRRIGATION AROUND THE IMPLANT WAS PERFORMED THREE (3) TIMES AND THE PATIENT WAS RELEASED.

  Patient problems: Osteolysis

  MAUDE report 22372896 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANT AT TOOTH LOCATION #5 WAS PLACED, NO DENTIST WOULD RESTORE THE IMPLANT DUE TO BONE LOSS. BONE GRAFTING AND IRRIGATION AROUND THE IMPLANT WAS PERFORMED THREE (3) TIMES AND THE PATIENT WAS RELEASED.

  Patient problems: Osteolysis

  MAUDE report 22372764 ↗
• InjuryJun 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 #13 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22292732 ↗
• InjuryJun 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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22289519 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis

  MAUDE report 22197805 ↗
• InjuryMay 30, 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 #19 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 22118547 ↗
• 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 21983517 ↗
• InjuryApr 23, 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 #4 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 21895548 ↗
• InjuryApr 4, 2025Adverse 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21775318 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS AT TOOTH SITE #12. PATIENT SUFFERED PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21750653 ↗