OSSEOTITE® CERTAIN® IOSS511Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844868007166), received between Oct 23, 2020 and Mar 3, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 21503500 ↗
• 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) 2025 INFECTION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 21503432 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 19 LACKED PRIMARY STABILITY, AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011752 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 30 LACKED PRIMARY STABILITY AT PLACEMENT AND WAS REMOVED.. THE BONE IS VERY SOFT. WE PLACED A BONE GRAFT AT THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12699437 ↗
• InjuryJul 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE #3 WAS UNABLE TO PLACE DUE TO LACK OF PRIMARY STABILITY AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186151 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY DURING IMPLANT PLACEMENT. DOCTOR DID NOT COMPLETE THE PROCEDURE PLACING OTHER IMPLANT, A NEW IMPLANT WOULD BE PLACED IN 6 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11937560 ↗
• InjuryNov 5, 2020Adverse 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 LACKED PRIMARY STABILITY WHEN PLACING AND IT WAS REMOVED. NO OTHER IMPLANT WAS PLACED AT THE SAME SURGERY.

  Patient problems: No Information

  MAUDE report 10790984 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO LACK OF PRIMARY STABILITY DURING PLACEMENT. NO OTHER IMPLANT WAS PLACED TO COMPLETE THE SURGERY.

  Patient problems: No Information

  MAUDE report 10725677 ↗