OSSEOTITE® NT585Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00844868012108), received between Oct 17, 2019 and Mar 12, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE 27 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24578363 ↗
• InjuryJul 25, 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 #47 FAILED DUE TO PERI-IMPLANTITIS. SITE PRESENTED ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 22607429 ↗
• 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 #35 #36 & #45 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20813684 ↗
• 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 #35 #36 & #45 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20813683 ↗
• InjuryAug 26, 2024Adverse 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 20064085 ↗
• InjuryAug 26, 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 #25, #26, #27, AND #36 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. THE DOCTOR REPORTED INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20063392 ↗
• InjuryJun 11, 2024Adverse 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 #26 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR ALSO REPORTED INFLAMMATION, EDEMA, PAIN.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 19508278 ↗
• InjuryMar 18, 2024Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921007 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 14 WAS REMOVED DUE TO PERI-IMPLANTITS. THE PATIENT COMPLAINED OF SORE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17248913 ↗
• MalfunctionSep 2, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE MOUNT WAS DIFFICULT TO SEPARATE FROM THE IMPLANT. PATIENT WILL NOT HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 15349271 ↗
• InjuryAug 19, 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 PERI-IMPLANTITIS AT THE SITE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15261978 ↗
• MalfunctionApr 9, 2021Unsealed Device Packaging; Unsealed Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11639849 ↗
• MalfunctionMar 26, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED DEVICE MALFUNCTION. WHEN PLACING THE IMPLANT DOCTOR NOTICED TWO SKIPS IN THE HAND PIECE (40 NW). WHEN CHECKING AND REMOVING THE MOUNT DOCTOR NOTICED THAT 3 OF THE HEX THREADS WERE DAMAGED. IMPLANT WAS THEN MANUALLY REMOVED DUE TO THE IMPOSSIBILITY TO HANDLE THE IMPLANT THROUGH ITS CONNECTION. ANOTHER IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574002 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT HAD LACK OF PRIMARY STABILITY AND WAS REMOVED. DOCTOR PERFORMED BONE GRAFT AND DID NOT PLACE ANOTHER IMPLANT IN THE SAME SURGERY. TOOTH LOCATION UNKNOWN.

  Patient problems: No Information

  MAUDE report 11023442 ↗
• InjuryNov 6, 2020Adverse 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 10800457 ↗
• InjuryOct 23, 2020Adverse 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 Information

  MAUDE report 10725849 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO ACHIEVE PRIMARY STABILITY. NO OTHER IMPLANT WAS ABLE TO BE PLACED.

  Patient problems: No Information

  MAUDE report 9262849 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PRIMARY STABILITY WAS NOT ACHIEVED WITH IMPLANT NT585.

  Patient problems: No Information

  MAUDE report 9202664 ↗