OSSEOTITE® NT3211Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00844868011972), received between Mar 17, 2020 and Dec 4, 2025 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT A PART OF THE IMPLANT AT TOOTH SITE #13 WAS FRACTURED AND PATIENT WENT TO THE CLINIC WITH THE PIECE IN THEIR HAND. THE APICAL PART THAT REMAINED AT PLACE WAS REMOVED ON A POSTERIOR SURGERY. ONLY THE CONNECTION HALF OF THE IMPLANT WAS RETURNED. PATIENT EXPERIENCED PAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714874 ↗
• InjuryJan 15, 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: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21157700 ↗
• 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 44 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 21064983 ↗
• InjuryOct 31, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20576700 ↗
• MalfunctionMar 8, 2024Separation Failure; Separation Failure

  PURPLE EXTERNAL CONNECTION IMPLANT DOES NOT HAVE MOUNT, DOCTOR HAS SENT IT WITH THE IMPLANT, SO A MMC15 HAS BEEN ADDED AS ITEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866205 ↗
• InjurySep 28, 2023Fracture; Unintended Movement; Fracture; Unintended Movement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17832176 ↗
• InjuryJul 11, 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 #21. THEREFORE, THE IMPLANT WAS REMOVED DUE TO FAILURE AND REPLACED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17303202 ↗
• MalfunctionFeb 17, 2023Mechanical 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 16397777 ↗
• MalfunctionAug 18, 2021Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335304 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

  Patient problems: Bone Fracture(s); Inflammation; Osteolysis; Pain

  MAUDE report 11690680 ↗
• MalfunctionOct 29, 2020Separation Failure; Separation Failure

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

  Patient problems: No Information

  MAUDE report 10754862 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR TRIED TO PLACE THE DENTAL IMPLANT AND THERE WAS NO PRIMARY STABILITY AND IT WAS REMOVED. DOCTOR CLOSED THE SITE AND WILL WAIT TO PLACE ANOTHER IMPLANT.

  Patient problems: No Information

  MAUDE report 9844245 ↗