OSSEOTITE® NT511Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00844868012078), received between Jun 11, 2020 and May 26, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Fracture” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO BONE LOSS AND PERI-IMPLANTITIS THE PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25284135 ↗
• InjuryNov 4, 2025Adverse 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 23469355 ↗
• InjuryJun 26, 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 NUMBER #25 FAILED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22335476 ↗
• InjuryMay 5, 2025Fracture; Fracture

  IT WAS REPORTED AN IMPLANT AT TOOTH SITE #36 FRACTURED AT THE COLLAR. PAIN WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS COMPLETELY REMOVED.

  Patient problems: Pain

  MAUDE report 21959505 ↗
• InjuryDec 23, 2024Mechanical Problem; Mechanical Problem

  THE DOCTOR REPORTS THAT THE IMPLANT HAS A DAMAGED DRIVE FEATURE AND WAS REMOVED, AS THE ABUTMENTS CANNOT BE SCREWED INTO THE IMPLANT. AFFECTED DENTAL POSITION 36 AND BONE TYPE II.PROCEDURE NOT COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20999758 ↗
• InjuryNov 30, 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 # 26 & # 25 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20813631 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO PERI-IMPLANTITIS. ADDITIONAL APPOINTMENT REQUIRED: YES, NEW IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19815274 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED BONE LOSS AT TOOTH SITES 44, 43.

  Patient problems: Osteolysis

  MAUDE report 19024876 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED BONE LOSS AT TOOTH SITES 44, 43.

  Patient problems: Osteolysis

  MAUDE report 19021356 ↗
• InjuryMar 31, 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: No Clinical Signs, Symptoms or Conditions; Sinus Perforation

  MAUDE report 16659197 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (NT511) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 4.

  Patient problems: Unspecified Infection

  MAUDE report 10501495 ↗
• InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (NT511) WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT LACK OF PRIMARY STABILITY AND IT WAS REMOVED. TOOTH LOCATION 6.

  Patient problems: No Information

  MAUDE report 10496015 ↗
• InjuryJul 15, 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 PERI-IMPLANTITIS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10275463 ↗
• InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO PLACE IN OSTEOTOMY. A NEW IMPLANT WILL BE PLACED IN 3 MONTHS. TOOTH LOCATION 26.

  Patient problems: No Information

  MAUDE report 10145721 ↗