OSSEOTITE® CERTAIN® XIFNT415Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00844868021988), received between Nov 6, 2020 and Jul 10, 2025 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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

• InjuryJul 10, 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 #6 WAS REMOVED TO DO A BONE REDUCTION FOR A FULL ARCH PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22476253 ↗
• MalfunctionMay 20, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT CLINICIAN HAD TO CHANGE THE IMPLANT BECAUSE THEY STRIPPED THE HEAD OF THE IMPLANT WHILE TRYING TO INSTALL IT. TOOTH SITE #32 REMOVED. PROCEDURE COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056353 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN FEELING PAIN SINCE THE IMPLANT AT TOOTH LOCATION # 21 WAS PLACED. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 19126064 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 15 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND EDEMA WERE REPORTED AS A RESULT OF THE EVENT. PATIENT HAD TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18226618 ↗
• MalfunctionOct 24, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993474 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION THE PATIENT HAD A FOLLOW UP (F/U) WITH GENERAL DENTIST WHO NOTICED PURULENCE. THE NEXT DAY THE PATIENT F/U FOR IMPLANT REMOVAL DUE TO INFECTION AT IMPLANT TOOTH SITE #12.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 17770299 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN IN THE AREA OF THE IMPLANT AT TOOTH LOCATION #12. THE IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17623025 ↗
• InjuryAug 9, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING IMPLANT PLACEMENT THE INTERNAL CONNECTION WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17490551 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Pain

  MAUDE report 17395860 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17225796 ↗
• InjuryMay 11, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pseudoaneurysm

  MAUDE report 16911097 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH 15 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Abscess; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16854686 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT DEVELOPED INFECTION, #5, #6 AND #7. IMPLANT WAS SUPPURATING FRANK PUS AT TOOTH #7. IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 15771599 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED IMMEDIATE IMPLANT PLACED AND TEMPORIZED SAME DAY. PATIENT RETURNED 3 WEEKS LATER, THOUGHT ABUTMENT SCREW WAS LOOSE, BUCCAL PLATE FRACTURED AND IMPLANT FAILED. IMPLANT WAS REMOVED. TOOTH SITE # 8 (UNIVERSAL). THE SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Bone Fracture(s)

  MAUDE report 14013577 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  XIFNT415 UNABLE TO PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12670814 ↗
• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO LACK OF PRIMARY STABILITY THE IMPLANT WAS REMOVED AND THE AREA GRAFTED. PATIENT WILL BE RETURNING FOR FUTURE IMPLANT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12420294 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS SIX MONTHS AFTER ITS PLACEMENT, THE DOCTOR ALSO REPORTED INFLAMMATION AND PAIN IN THE IMPLANT. THE DOCTOR CONFIRMS THAT THE PATIENT DID NOT SUFFER ANY IMPACT ON HIS HEALTH. THE DOCTOR ALSO CONFIRMS THAT HE REMOVED THE IMPLANT AND PLACED ANOTHER IN THE SAME SURGERY

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 12336969 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS PLACED IN TOOTH LOCATIONS # 10 AND 13 HAD A BIG BONE LOSS IN THE SITES, PERI-IMPLANTITIS AND INFLAMMATION. THE IMPLANTS WERE REMOVED.

  Patient problems: No Code Available

  MAUDE report 11008011 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS PLACED IN TOOTH LOCATIONS # 10 AND 13 HAD A BIG BONE LOSS IN THE SITES, PERI-IMPLANTITIS AND INFLAMMATION. THE IMPLANTS WERE REMOVED.

  Patient problems: No Code Available

  MAUDE report 11007897 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THE IMPLANT IN TOOTH LOCATION 13 WAS REMOVED DUE TO PERI-IMPLANTITIS. SITE HAD INFLAMMATION.

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10799964 ↗