OSSEOTITE® CERTAIN® INT513Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00844868006718), received between Dec 20, 2019 and Dec 16, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis

  MAUDE report 23822200 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON (B)(6) 2025, THE PATIENT RECEIVED AN OSTEOTOMES AND A VERTICAL SINUS LIFT AND AN IMPLANT WAS PLACED AT TOOTH SITE #12. ON (B)(6) 2025, THE PATIENT PRESENTED WITH SIGNIFICANT BONE LOSS AND POSSIBLE LOSS OF THE BUCCAL PLATE. THE IMPLANT WAS REMOVED AND REPLACED WITH A ZIMMER BIOMET OR ZIMVIE SYSTEM.

  Patient problems: Osteolysis

  MAUDE report 23526647 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20439921 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis

  MAUDE report 20321004 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20304841 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTED THAT THE DENTAL IMPLANT FAILED DUE TO BONE LOSS. THE DOCTOR ALSO REPORTS PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 15903785 ↗
• InjurySep 2, 2022Mechanical Problem; Mechanical Problem

  DOCTOR REPORTED THAT INTERNAL PROSTHETIC CONNECTION IS DAMAGED. THE DOCTOR ALSO REPORTED EDEMA AND POOR BONE QUALITY. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Swelling/ Edema

  MAUDE report 15348516 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO MEDICAL BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 14517028 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO MEDICAL BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 14516494 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED INTO THE OSTEOTOMY DUE TO THE LACK OF PRIMARY STABILITY AND A LARGE SOCKET. PATIENT WILL RETURN FOR A NEW IMPLANT. TOOTH #29.

  Patient problems: No Information

  MAUDE report 10436454 ↗
• InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED IN SITE 4.

  Patient problems: No Information

  MAUDE report 9976871 ↗
• InjuryJan 30, 2020Adverse 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

  MAUDE report 9648809 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS UNABLE TO PLACE THE IMPLANT INTO THE PATIENT'S OSTEOTOMY DUE TO A LACK OF PRIMARY STABILITY.

  Patient problems: No Information

  MAUDE report 9502980 ↗