OSSEOTITE® FNT585Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00844868003410), received between Nov 20, 2019 and Nov 14, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED AN ALVEOLAR PROCESS FRACTURE OF THE MAXILA IN BLOCK AT TOOTH SITE OF 24-25. IMPLANTS WERE REMOVED. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANT. SYMPTOMS REPORTED ON THE PATIENT: PAIN, ABSCESS AND INFLAMMATION.

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

  MAUDE report 23553059 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS AT TOOTH SITE #34-44-46. PATIENT SUFFERED INFLAMMATION AND PAIN. IMPLANTS WERE REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21916702 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITES 45/46/47/44 OBSERVED DURING THE CLINICAL PROCEDURE AND 5 IMPLANTS WERE REMOVED. EXTERNAL PATIENT WENT TO THE CLINIC WITH PERI-IMPLANTITIS AND BONE LOSS AROUND THE IMPLANT. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANTS AND ADDITIONAL APPOINTMENT WILL BE REQUIRED. ABSCESS, INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21592008 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITES 45/46/47/44 OBSERVED DURING THE CLINICAL PROCEDURE AND 5 IMPLANTS WERE REMOVED. EXTERNAL PATIENT WENT TO THE CLINIC WITH PERI-IMPLANTITIS AND BONE LOSS AROUND THE IMPLANT. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANTS AND ADDITIONAL APPOINTMENT WILL BE REQUIRED. ABSCESS, INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21591936 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITES 45/46/47/44 OBSERVED DURING THE CLINICAL PROCEDURE AND 5 IMPLANTS WERE REMOVED. EXTERNAL PATIENT WENT TO THE CLINIC WITH PERI-IMPLANTITIS AND BONE LOSS AROUND THE IMPLANT. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANTS AND ADDITIONAL APPOINTMENT WILL BE REQUIRED. ABSCESS, INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21591860 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WITH REMOVABLE PROSTHESIS, PERIODONTAL CONDITION AND SMOKER. IMPLANT 14 STARTED TO MOVE DUE TO PERIIMPLANTITIS AND WAS REMOVED. BONE CURETTAGE AND COLLAGEN FILLING. PAIN, INFLAMMATION AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT. A ROG (GUIDED BONE REGENERATION) WILL BE REQUIRED TO REPLACE ANOTHER IMPLANT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20366305 ↗
• InjuryApr 15, 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 & 27 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: III. THE DOCTOR REPORTED : SMOKER.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19106177 ↗
• InjuryDec 4, 2023Adverse 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 #46 FAILED DUE TO INFECTION. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED DIABETES + PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18255080 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH #16/17 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15736454 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITES # 29, 30 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 12445674 ↗
• InjuryJan 13, 2021Adverse 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 11161076 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT IN TOOTH LOCATION 26 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10513595 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT IN TOOTH LOCATION 24 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10513558 ↗
• InjuryMar 25, 2020Fracture; Fracture

  IT WAS REPORTED AT THE IMPLANT "RACTURED" AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Pain

  MAUDE report 9878177 ↗
• InjuryMar 25, 2020Fracture; Fracture

  IT WAS REPORTED IMPLANT FRACTURED AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Pain

  MAUDE report 9877995 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION AD THE IMPLANT SITE AND THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9378120 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (FNT585) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 3.

  Patient problems: Unspecified Infection

  MAUDE report 9347400 ↗