OSSEOTITE® CERTAIN® INT3213Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00844868006619), received between Jun 12, 2020 and Jun 9, 2026 — classified as 20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITES # (B)(6) AND # (B)(6) WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION AND ABSCESS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25448816 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITES #32 AND #42 WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION AND ABSCESS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25448763 ↗
• InjurySep 17, 2025Adverse 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 #34 & #35 FAILED DUE TO PERI-IMPLANTITIS. DISCOVERED DURING CHECK UP DUE TO CROWN MOBILITY AND INFLAMMATION. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23072097 ↗
• InjurySep 17, 2025Adverse 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 #34 & #35 FAILED DUE TO PERI-IMPLANTITIS. DISCOVERED DURING CHECK UP DUE TO CROWN MOBILITY AND INFLAMMATION. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23072095 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #42 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21535880 ↗
• InjuryAug 19, 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 #31 #33 #35 & #39 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: IV.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20000141 ↗
• InjuryJul 8, 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 33 AND 43 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19688877 ↗
• InjuryJul 8, 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 33 AND 43 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19688863 ↗
• InjuryFeb 6, 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 THE BUCCAL POSITIONS NUMBERS 23 FAILED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16305521 ↗
• InjuryJan 3, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT FAILED DUE TO AN ALLERGIC REACTION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16086158 ↗
• MalfunctionSep 2, 2022Mechanical Problem; Mechanical Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION #21 FAILED BECAUSE DURING THE POSITIONING OF THE IMPLANT INSIDE THE SITE, AN INCORRECT COUPLING BETWEEN THE DRIVER AND THE IMPLANT WAS HIGHLIGHTED, THEREFORE IT WAS NOT POSSIBLE TO POSITION IT. THE DENTAL PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT AND THE PATIENT DID NOT SUFFER ANY TYPE OF NEGATIVE IMPACT ON HIS HEALTH AS A CONSEQUENCE OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351166 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTED THAT THE DENTAL IMPLANT FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15073343 ↗
• InjuryFeb 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 BONE LOSS AND PAIN AT THE SITE. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS.

  Patient problems: Osteolysis; Pain

  MAUDE report 13548664 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 10 LACKED PRIMARY STABILITY, AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843470 ↗
• InjuryJun 18, 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. TOOTH LOCATION 12. ABSCESS AND BONE LOSS WERE NOTED.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 12026051 ↗
• InjuryMay 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT AT TOOTH LOCATION # 26 LACKED PRIMARY STABILITY AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829774 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXTRACTION AND IMMEDIATE IMPLANT PLACEMENT IN THE AREA OF #29. NOT ENOUGH STABILITY TO PLACE IMPLANT INT3213.

  Patient problems: No Information

  MAUDE report 11170329 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY DURING SURGERY AND WAS REMOVED. NO OTHER IMPLANT PLACED DURING THE SAME SURGERY.

  Patient problems: No Information

  MAUDE report 10395411 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT DID NOT ACHIVE PRIMARY STABILITY DURING SURGERY AND WAS REMOVED. NO OTHER IMPLANT PLACED DURING THE SAME SURGERY.

  Patient problems: No Information

  MAUDE report 10356219 ↗
• InjuryJun 12, 2020Adverse 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 LACK OF PRIMARY STABILITY. ANOTHER IMPLANT WOULD BE PLACED.

  Patient problems: No Information

  MAUDE report 10147849 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO LACK OF PRIMARY STABILITY. ANOTHER IMPLANT WOULD BE PLACED.

  Patient problems: No Information

  MAUDE report 10147823 ↗