OSSEOTITE® CERTAIN® IOSS411Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00844868007098), received between Oct 23, 2020 and May 19, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 8, 2016Terminated

   Product was incorrectly packaged.

   Z-2845-2016 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT REMOVED WITH REMOVAL KIT. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25219927 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #11 WAS FAILING DUE TO BONE LOSS AND WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 24988086 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO EARLY CRESTAL BONE LOSS. TOOTH NUMBER 13.

  Patient problems: Osteolysis

  MAUDE report 24629469 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED HEAVY BONE LOSS DUE TO PERI-IMPLANTITIS - WILL TRY TO GRAFT BEFORE ANOTHER TRY. TOOTH NUMBER 31.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24201888 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. THE AFFECTED TOOTH SITE NUMBER WAS NOT PROVIDED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21410049 ↗
• InjuryDec 18, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18343400 ↗
• InjuryDec 18, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18343370 ↗
• InjuryJan 3, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT FAILED DUE TO AN ALLERGIC REACTION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16086189 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INFECTION WITH PAIN AND SWELLING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13889763 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT AN UNKNOWN TOOTH SITE LACKED PRIMARY STABILITY, AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787629 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 WEEKS AFTER PLACEMENT IMPLANT AT TOOTH SITE # 30 BECAME INFECTED HAD TO BE REMOVED. PATIENT NOT RETURNING FOR IMPLANT RE-PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, EDEMA, INFECTION, INFLAMMATION & PAIN.

  Patient problems: Abscess; Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 12451471 ↗
• InjuryAug 24, 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: Osteolysis; Sinus Perforation; Unspecified Infection

  MAUDE report 12358399 ↗
• InjuryJul 22, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12209647 ↗
• 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 #19 WAS UNABLE TO PLACE DUE TO LACK OF PRIMARY STABILITY AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186139 ↗
• InjuryNov 2, 2020Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 10769281 ↗
• InjuryOct 23, 2020Adverse 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 PLACEMENT AND IT WAS REMOVED. NO OTHER IMPLANT WAS PLACED TO COMPLETE THE SURGERY.

  Patient problems: No Information

  MAUDE report 10725801 ↗