OSSEOTITE® OSS510Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00844868013259), received between Oct 31, 2019 and Sep 25, 2024 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT AFTER IMPLANTATION THERE WAS AN INFECTION AT TOOTH SITE 26. IT WAS TREATED AND IT APPARENTLY HAPPENED APPROXIMATELY TWO MONTHS AGO.

  Patient problems: Unspecified Infection

  MAUDE report 20300478 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT AFTER IMPLANTATION THERE WAS AN INFECTION ON (B)(6) 2024 WHICH WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 20300471 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THE IMPLANT LOST INTEGRATION DURING UNCOVERING DUE TO PERI-IMPLANTITIS AND WAS REMOVED. TOOTH SITE 26.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20300278 ↗
• InjuryJul 8, 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.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19687639 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT LACKED PRIMARY STABILITY WHEN PLACING AND WAS REMOVED.

  Patient problems: No Information

  MAUDE report 10435908 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UDI NUMBER HAS BEEN CORRECTED. SEE H10.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10213492 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE IMPLANT WAS EXTRACTED.

  Patient problems: Unspecified Infection

  MAUDE report 9364352 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (OSS510) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 31. SITE WAS BONE GRAFTED.

  Patient problems: Unspecified Infection

  MAUDE report 9363770 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: No Information

  MAUDE report 9262618 ↗