OSSEOTITE® CERTAIN® IOSS413Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00844868007104), received between Oct 28, 2019 and May 15, 2025 — 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.

• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER INDICATED: UNCOVERED IMPLANT IN DENTAL SITE 7 WITH PUSS. RESTORATION. IMPLANT HAD TO BE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: GRAFTED: NO.

  Patient problems: Unspecified Infection

  MAUDE report 22025091 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS CONTRIBUTED TO GRADUAL LOSS OF INTEGRATION, TOOTH 4.IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20529904 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15162003 ↗
• InjuryMay 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT AT TOOTH LOCATION # 5 WAS REMOVED DUE TO LACK OF PRIMARY STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905557 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED APICAL INFECTION AROUND # 8 IMPLANT. PATIENT DID NOT TAKE HER POST-OP ANTIBIOTIC DUE TO WORRY ABOUT GI ASPECT. IMPLANT AT TOOTH SITE # 8 WAS REMOVED DUE TO INFECTION AROUND IMPLANT. ADDITIONAL APPOINTMENTS / IMPLANT RE-PLACEMENT: NOT INDICATED. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11645340 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE 14 LACKED PRIMARY STABILITY WHEN PLACING AND IT WAS REMOVED. PROCEDURE WAS NOT COMPLETED USING ANOTHER IMPLANT.

  Patient problems: No Information

  MAUDE report 10732710 ↗
• InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (IOSS413) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 6. DOCTOR DECIDED TO REMOVE THE IMPLANT AS PATIENT HAD A PREVIOUS CONDITION PRIOR TO THE IMPLANT PLACEMENT. PAIN WAS ALSO REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10708584 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PRIMARY STABILITY COULD NOT BE ACHIEVED WITH IMPLANT IOSS413 IN TOOTH LOCATION #8.

  Patient problems: No Information

  MAUDE report 9917165 ↗
• InjuryOct 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE PATIENT DEVELOPED INFECTION AROUND IMPLANT IOSS413 IN TOOTH SITE # 28 THREE WEEKS AFTER PLACEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 9247085 ↗