OSSEOTITE® NT3210Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844868011965), received between Dec 3, 2019 and Apr 3, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24782117 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 24 LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION, SWELLING AND ABSCESS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24779096 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT UR1 LOOSE AT SECOND STAGE DUE TO PERI IMPLANTITIS. PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19743039 ↗
• MalfunctionApr 5, 2023Mechanical Problem; Mechanical Problem

  ROUNDED OUT HEX ON PLACEMENT IN DENSE BONE. IMPLANT REMOVED WITH FORCEPS. NO PATIENT IMPACT AND NO DELAY IN THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683951 ↗
• MalfunctionNov 18, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS DAMAGED TO THE IMPLANT'S DRIVE FEATURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824081 ↗
• MalfunctionFeb 17, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING IMPLANT PLACEMENT , THE IMPLANT ACHIEVED GOOD PRIMARY STABILITY. BUT THEN, THE DOCTOR WAS UNABLE TO PLACE COVER SCREW. THE INTERNAL THREAD WAS DAMAGED. IMPLANT WAS REMOVED AND REPLACED WITH SUCCESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13547759 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9400645 ↗
• InjuryDec 3, 2019Adverse 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 Code Available; Unspecified Infection

  MAUDE report 9400088 ↗