OSSEOTITE® NT413Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00844868012030), received between Jan 27, 2020 and Apr 3, 2026 — classified as 29 injuries.

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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24779687 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24367173 ↗
• InjuryOct 21, 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 #16 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23347662 ↗
• InjuryMar 20, 2025Adverse 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. TOOTH LOCATION 4 (UNIVERSAL).

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21650662 ↗
• InjuryJan 3, 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 36 AND 46 HAD MOBILITY AND WERE REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A CONSEQUENCE OF THE EVENT. CURETTAGE WAS PERFORMED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21065475 ↗
• InjuryJan 3, 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 36 AND 46 HAD MOBILITY AND WERE REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A CONSEQUENCE OF THE EVENT. CURETTAGE WAS PERFORMED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21065453 ↗
• InjuryJan 3, 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 46 HAD MOBILITY AND WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A CONSEQUENCE OF THE EVENT. CURETTAGE WAS PERFORMED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21065320 ↗
• InjuryJan 3, 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 24 HAD MOBILITY AND WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A CONSEQUENCE OF THE EVENT. CURETTAGE WAS PERFORMED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21065291 ↗
• InjuryJan 3, 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 24 AND 26 WERE REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21065149 ↗
• InjuryJan 3, 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 21 HAD MOBILITY AND WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A CONSEQUENCE OF THE EVENT CURETTAGE PERFORMED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21065068 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE 15 HAD MOBILITY AND WERE REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A CONSEQUENCE OF THE EVENT. CURETTAGE WAS PERFORMED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21064830 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE 15 HAD MOBILITY AND WERE REMOVED WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A CONSEQUENCE OF THE EVENT. CURETTAGE WAS PERFORMED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21064758 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTIST REMOVED THE IMPLANT DUE TO AN INFECTION ON TOOTH SITE #5. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20641283 ↗
• InjuryOct 31, 2024Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578460 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BONE LOSS AT TOOTH SITES 12 AND 47. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Osteolysis; Pain

  MAUDE report 20511963 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS A VERY AGGRESSIVE PERI-IMPLANTITIS AT TOOTH SITE 26 SEVERAL MONTHS AFTER IMPLANT LOADING, PERFORMED USING THE "COLUMBUS BRIDGE" PROCEDURE, AND IMPLANT HAD TO BE REMOVED. PROCEDURE WAS COMPLETED WITH OTHER IMPLANT. PAIN, EDEMA, INFLAMMATION AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 20222519 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 22 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT. PATIENT WILL RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19742867 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE DOCTOR THAT THE PATIENT DEVELOPED PERI-IMPLANTITIS AND INFLAMMATION AT IMPLANT TOOTH SITE #23. THEREFORE, THE IMPLANT WAS REMOVED DUE TO FAILURE.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17318768 ↗
• InjuryFeb 17, 2023Adverse 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; Unspecified Infection

  MAUDE report 16396410 ↗
• InjuryMar 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS WITH ABSCESS AND INFLAMMATION. PATIENT IS SMOKER.

  Patient problems: Abscess; Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 13678161 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT IN LACKED OF PRIMARY STABILITY AND WAS REMOVED. DOCTOR DID NOT PLACE ANOTHER IMPLANT IN THE SURGERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12671235 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT NT413 IN TOOTH # 31 (FDI) POSITION WAS REMOVED DUE TO PERI-IMPLANTITIS, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 11397890 ↗
• InjuryFeb 12, 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. THE ALLEGED DEVICE WAS NOT RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 11321606 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN PLACING THE IMPLANT IN THE SITE 5 IT LACKED PRIMARY STABILITY WHEN PLACING AND WERE REMOVED. AFTER THE SECOND ATTEMPT TO PLACE THE IMPLANT, DOCTOR DID NOT TRY TO PLACE A THIRD ONE AND CLOSED THE SITE. PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: No Information

  MAUDE report 10875187 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10874949 ↗