OSSEOTITE® CERTAIN® IOSS585Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868007197), received between Dec 18, 2019 and Aug 16, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  Doctor reported that implant was removed due to Peri-implantitis with complete loss of integration. Tooth site 26.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50266169 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION AT TOOTH SITES 26-27. AFTER 3 WEEKS OF IMPLANTATION, IT WAS REPORTED INFECTION. IT WAS TREATED WITH ANTIBIOTICS ON (B)(6) 2025 AND, A WEEK LATER ON (B)(6) 2025, IT WAS DECIDED TO REMOVE THE IMPLANTS. ABSCESS, INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT. THIS REPORT REFERS TO (B)(6) INFECTION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 21503528 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION AT TOOTH SITES 26-27. AFTER 3 WEEKS OF IMPLANTATION, IT WAS REPORTED INFECTION. IT WAS TREATED WITH ANTIBIOTICS ON (B)(6) 2025 AND, A WEEK LATER ON (B)(6) 2025, IT WAS DECIDED TO REMOVE THE IMPLANTS. ABSCESS, INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT. THIS REPORT REFERS TO (B)(6) INFECTION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 21503291 ↗
• InjuryMay 8, 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: Pain

  MAUDE report 19270920 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTED THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #19 FAILED DUE TO PERI-IMPLANTITIS. THE SYMPTOM AS A RESULT OF THE EVENT IS PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 16725537 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 14 LACKED PRIMARY STABILITY AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12452363 ↗
• InjuryDec 18, 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 Information; Unspecified Infection

  MAUDE report 9487266 ↗