OSSEOTITE® CERTAIN® IFNT511Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00844868005063), received between Nov 26, 2020 and Jun 30, 2025 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 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 PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22353070 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR INDICATED LOSS OF INTEGRATION, SINUS PERFORATION. THE IMPLANT WAS REMOVED. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO. GRAFTED: ALLOPLAST PLACED WITH IMPLANT PLACEMENT. TOOTH SITE: 3. ON A FOLLOW UP RECEIVED ON (B)(6), 2025, CUSTOMER RESPONDED STATING THE PERFORATION TO SINUSES WAS MINIMAL AND WAS TREATED WITH A COLLAGEN PLUG.

  Patient problems: Sinus Perforation

  MAUDE report 22071658 ↗
• InjuryMar 7, 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. PATIENT PRESENTED WITH PAIN AND DRAINAGE. PATIENT WISHED REMOVAL. TOOTH 29. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND DRAINAGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Unspecified Infection

  MAUDE report 21546950 ↗
• InjuryFeb 26, 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 #18 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 21468597 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AND BLEEDING AROUND THE IMPLANT AT TOOTH LOCATION #14. PERI-IMPLANTITIS WAS NOTED AND THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21468466 ↗
• InjuryMay 23, 2024Adverse 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 PERI IMPLANTITIS ON PATIENT'S REQUEST. TOOTH SITE # 19. SYMPTOMS: GROSS INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19386476 ↗
• InjuryNov 17, 2023Adverse 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 18161988 ↗
• MalfunctionFeb 23, 2023Mechanical Problem; Mechanical Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16428605 ↗
• InjuryDec 30, 2021Adverse 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: Inflammation; Osteolysis

  MAUDE report 13117759 ↗
• InjurySep 23, 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 PERI-IMPLANTITIS AND A LOSS OF INTEGRATION. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #9.

  Patient problems: Inadequate Osseointegration; Osteolysis; Unspecified Infection

  MAUDE report 12520489 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PATIENT PRESENTED WITH MOBILITY OF IMPLANT AT TOOTH SITE #14 DUE TO PERI-IMPLANTITIS AND THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12507290 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #19 HAD TO BE REMOVED DUE TO SIGNIFICANT BONE LOSS RESULTING IN THE IMPLANT BECOMING LOOSE.

  Patient problems: Osteolysis

  MAUDE report 12136074 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT HAD TO BE REMOVED DUE TO THE PATIENT EXPERIENCING PAIN AND DISCOMFORT AFTER BEING RESTORED. IMPLANT WAS REMOVED AND REPLACED WITH ANOTHER BIOMET IMPLANT. TOOTH #30.

  Patient problems: Discomfort; Pain

  MAUDE report 12128237 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AT TOOTH LOCATION 30. INFLAMMATION, EDEMA AND LOSS INTEGRATION WERE ALSO REPORTED.

  Patient problems: Edema; Inflammation; Unspecified Infection

  MAUDE report 11127209 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AND INFLAMMATION AROUND THE IMPLANT. SYMPTOMS AS A RESULT: LOSS INTEGRATION, EDEMA.

  Patient problems: Edema; Inflammation; No Code Available

  MAUDE report 11117552 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AND INFLAMMATION AROUND THE IMPLANT. SYMPTOMS AS A RESULT: LOSS INTEGRATION, EDEMA.

  Patient problems: Edema; Inflammation; No Code Available

  MAUDE report 11116148 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation; No Code Available

  MAUDE report 11004076 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AT TOOTH LOCATION 19. EDEMA WAS ALSO REPORTED.

  Patient problems: Edema; Unspecified Infection

  MAUDE report 10908635 ↗