OSSEOTITE® CERTAIN® INT413Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00844868006664), received between Nov 20, 2019 and Sep 29, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  The doctor reports that the dental implants failed due to peri-implantitis at tooth sites 16 and 17.The doctor reports in the PER that the procedure was not concluded by placing another implants.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50931699 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  The doctor reports that the dental implants failed due to peri-implantitis at tooth sites 16 and 17.The doctor reports in the PER that the procedure was not concluded by placing another implants. Site grafted.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50931627 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED FROM TOOTH SITE #34, DUE TO INFECTION AND BONE LOSS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23730228 ↗
• 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 19490801 ↗
• 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 19482108 ↗
• InjuryMar 6, 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. ABSCESS, EDEMA, PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 18844912 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 13, 18, 21, 23 WERE REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND EDEMA WERE REPORTED AS A RESULT OF THE EVENT. PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 18426596 ↗
• 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 17815455 ↗
• 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 17815420 ↗
• 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 17815325 ↗
• InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  T WAS REPORTED THAT IMPLANT AT TOOTH SITE 11 WAS REMOVED DUE TO PERI-IMPLANTITIS. EDEMA AND PAIN WERE REPORTED AS A RESULT OF THE EVENT. PROCEDURE WAS COMPLETED WITH REGENERATION.

  Patient problems: Osteolysis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16972282 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH 6 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16946380 ↗
• 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 10 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16443732 ↗
• InjuryAug 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANT HAD TO BE REMOVED DUE TO THE PATIENT HAVING AN ALLERGIC REACTION WITH PAIN AT THE SITE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 15298225 ↗
• InjuryAug 5, 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 #5 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15175720 ↗
• InjuryJul 22, 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 #5 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15084428 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH 26 WAS REMOVED DUE TO BONE LOSS. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 13590640 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RECEIVED IMPLANT AND NEVER CAME BACK, NEVER UNCOVERED THE IMPLANT. THE PATIENT RETURNED WITH PAIN AND IMPLANT WAS LOOSE WITH BONE LOSS. AFTER CONFIRMATION WITH XRAY THE IMPLANT WAS REMOVED. TOOTH # 6.

  Patient problems: Osteolysis; Pain

  MAUDE report 12913018 ↗
• 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 12331246 ↗
• InjuryJun 25, 2021Adverse 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: Inflammation; Pain; Unspecified Infection

  MAUDE report 12067244 ↗
• InjuryJun 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANTS AT TOOTH SITES # 14, 19 WERE REMOVED DUE TO LACK OF PRIMARY STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988643 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT (INT413) WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT DID NOT ACHIEVE PRIMARY STABILITY AND IT WAS REMOVED. TOOTH LOCATION 10.

  Patient problems: No Information

  MAUDE report 10105239 ↗
• InjuryNov 20, 2019Adverse 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. TOOTH LOCATION 15.

  Patient problems: Unspecified Infection

  MAUDE report 9350203 ↗