OSSEOTITE® CERTAIN® INT415Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00844868006671), received between Aug 14, 2020 and Jul 15, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN POSITION #33 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22514060 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER 32 42 & 45 FAILED DUE TO PERI-IMPLANTITIS. PATIENT HAD A HEART ATTACK AND TOOK SOME MEDICINE DURING POST SURGERY PERIOD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. THE DOCTOR REPORTED PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19490339 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #13 #23 #16 & #26 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANTS. PATIENT FELT PAIN AND SITE PRESENTED INFLAMMATION AND EDEMA.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17815520 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 16 AND 17 WERE REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION, PAIN AND DISCOMFORT WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Discomfort; Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 17010839 ↗
• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE 4 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16443813 ↗
• InjuryFeb 27, 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 13 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16443782 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION 36 WAS REMOVED DUE TO PERI-IMPLANTITIS. ONLY 4/6MM. ADDITIONAL APPOINTMENT REQUIRED: YES, TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15303474 ↗
• MalfunctionJun 15, 2022Device Damaged by Another Device; Device Damaged by Another Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14694993 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITES # UNKNOWN LACKED PRIMARY STABILITY AND WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331448 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMMEDIATE IMPLANT PLACEMENT WAS ATTEMPTED AND THERE WAS LACK OF PRIMARY STABILITY DUE TO SOFT BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163252 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMMEDIATE IMPLANT PLACEMENT WAS ATTEMPTED AND THERE WAS LACK OF PRIMARY STABILITY DUE TO SOFT BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163157 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 6 WAS UNABLE TO PLACE IN OSTEOTOMY.

  Patient problems: No Information

  MAUDE report 10832630 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10406507 ↗