OSSEOTITE® CERTAIN® XIFNT513Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00844868022022), received between Oct 18, 2019 and Jul 29, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implants at tooth sites 22 (XIITP4313) and 23 (XIFNT513) were removed due to periimplantitis.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50066514 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITES #22 AND #24 WERE REMOVED DUE TO ACUTE PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24501028 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23720348 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 16/25/36/UNKNOWN/UNKNOWN WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22410911 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 16/25/36/UNKNOWN/UNKNOWN WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22410832 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 15, 24, 45 WERE REMOVED DUE TO SEVERE PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21983135 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN, SWELLING.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21462840 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 20457069 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BONE LOSS AND INFECTION AT IMPLANT TOOTH SITE #8. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18414302 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED INFECTION AND BONE LOSS AROUND IMPLANT T3ST413. THREE DENTAL IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS IN EARLY STAGE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17883566 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #12 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16869669 ↗
• MalfunctionNov 22, 2022Device Damaged Prior to Use; Defective Device; Device Damaged Prior to Use; Defective Device

  IT WAS REPORTED THAT THE COVER SCREW IS FOLDED IN ITS PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15844418 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO AN INFECTION AT THE SITE. PATIENT WILL RETURN FOR A NEW IMPLANT IN THE FUTURE.

  Patient problems: Unspecified Infection

  MAUDE report 15162575 ↗
• InjuryJun 16, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED INSIDE STRIPPED WHEN TORQUE. PER INDICATES IMPLANT PLACED AND REMOVED IMMEDIATELY DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14713720 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PATIENT DEVELOPED PARESTHESIA OF HER RIGHT CHIN AND LIP. THE IMPLANT WAS REMOVED. TOOTH SITE # 29 (UNIVERSAL).

  Patient problems: Paresthesia

  MAUDE report 13692978 ↗
• InjuryAug 28, 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: Unspecified Infection

  MAUDE report 10464130 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (XIFNT513) WAS REMOVED DUE TO BONE LOSS. AFTER THREE MONTHS OF IMPLANT PLACEMENT, DOCTOR NOTICED BONE WAS CRESTALLY EXPOSED. IMPLANT WAS REMOVED. TOOTH LOCATION 5. SITE WAS BONE GRAFTED.

  Patient problems: No Code Available

  MAUDE report 10268465 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. PATIENT WILL RETURN FOR REPLACEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 9829328 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT (XIFNT513) WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT DID NOT ACHIEVE PRIMARY STABILITY AND IT WAS REMOVED. SITE WAS BONE GRAFTED. TOOTH LOCATION 20.

  Patient problems: No Information

  MAUDE report 9457279 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE AND THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9210061 ↗