OSSEOTITE® CERTAIN® XIFNT511Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00844868022015), received between Oct 18, 2019 and May 19, 2026 — classified as 56 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 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 IMPLANTS AT TOOTH SITES #46, #32, #42 AND UNKNOWN LOCATION WERE REMOVED DUE TO ACUTE PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25219126 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #46, #32, #42 AND UNKNOWN LOCATION WERE REMOVED DUE TO ACUTE PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25219033 ↗
• 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 24500955 ↗
• 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 23720320 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS. MOBILE FAILED TOOTH SITE: 30.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23589905 ↗
• MalfunctionNov 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED AS THE THREADS WERE DAMAGED. IMPLANT PLACED AND TRIED TO BACK IT OUT AND THE IMPLANT WAS STRIPPED. IT WAS HARD TO GET OUT AND NOW THE SCREW IS STRIPPED AND NO LONGER USEFUL. CLINICIAN WAS BACKING OUT THE IMPLANT AS THE BONE WAS TOO DENSE & THE IMPLANT WOULD NOT GO AS DEEP AS IT NEEDED. WHILE BACKING OUT THE IMPLANT; THE IMPLANT'S THREAD BECAME DAMAGED/STRIPPED & THEY COULD NOT PLACE A SCREW. SHE STATED THERE IS NOTHING WRONG WITH THE SCREW, ITS THE IMPLANT'S THREAD THAT BECAME DAMAGED. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586789 ↗
• InjuryAug 5, 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 #21 WAS REMOVED DUE TO BONE LOSS. BONE LOSS SURROUNDING RESTORED IMPLANT #21. REMOVAL OF IMPLANT WITH DEBRIDEMENT.SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION

  Patient problems: Inflammation; Osteolysis

  MAUDE report 22717360 ↗
• InjuryMay 24, 2025Adverse 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 BONE LOSS, TOOTH #19. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 22082117 ↗
• InjuryMay 22, 2025Fracture; Fracture

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #26 FAILED BECAUSE IT FRACTURED BY THE BODY AND WAS REMOVED. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE LOSS AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 22070995 ↗
• 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 21983130 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #46 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21618129 ↗
• InjuryDec 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 24 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20873545 ↗
• InjuryJul 15, 2024Adverse 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 PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19741400 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 26 WAS REMOVED DURING PROSTHETIC POST LOADING DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18239591 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EARLY ACUTE PERI-IMPLANTIS, NON-INTEGRATION, ROG. TEETH LOCATION: 10, 34, 31, 35. BONE DENSITY TYPE: III.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18221036 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO EARLY PERI-IMPLANTITIS. TOOTH LOCATION 47.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18091218 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF NUMBNESS THAT NEVER WENT AWAY. THROUGH X-RAYS, THE IMPLANT DID NOT SEEM TO EFFECT THE NERVE, HOWEVER THE PATIENT IS STILL NUMB IN THE CHIN AREA. THE IMPLANT WAS REMOVED. TOOTH LOCATION IS UNKNOWN.

  Patient problems: Numbness; Osteolysis

  MAUDE report 17375132 ↗
• InjuryJul 19, 2023Mechanical Problem; Mechanical Problem

  THE DOCTOR REPORTS THAT THE INTERNAL HEXAGON OF THE IMPLANT IS NOT SUITABLE AS THE KEY CANNOT BE ENGAGED WITH IT. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT COMPLETED USING ANOTHER IMPLANT. THE AFFECTED TOOTH POSITION IS #46.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17355275 ↗
• InjuryJul 19, 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 # 36 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17353159 ↗
• InjuryMay 24, 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: Nerve Damage; Paresthesia

  MAUDE report 16997319 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A HISTORY OF OSI PLACEMENT. AFTER UNCOVERY, PATIENT FOUND TO HAVE PAIN AND BONE LOSS. DEBRIDEMENT AND GRAFTING ATTEMPTED. PAIN AND MILD EDEMA AFTER 6 MONTHS AFTER GRAFTING. DECISION MADE TO REMOVE. TOOTH 19. IMPLANT REMOVED; SITE GRAFTED.

  Patient problems: Osteolysis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16385197 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH LOCATIONS 16, 22 AND 34 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16381919 ↗
• InjuryOct 6, 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 PERI-IMPLANTITIS..SYMPTOMS CAUSED BY THE EVENT: INFLAMMATION AND EDEMA. IMPLANT ALREADY REHABILITATED WITH CROWN ON (B)(6) 2021. LATE INSERTION LOSS. EXTREME BONE DEFECT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15551116 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON POST OP DAY 8, THE PATIENT PRESENTED WITH INFECTION, PAIN, SLIGHT SWELLING, INFLAMMATION AND IMPLANT MOBILITY AT TOOTH LOCATION #20 WHICH REQUIRED REMOVAL AND ANTIBIOTIC THERAPY.

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

  MAUDE report 14841968 ↗
• InjuryMay 12, 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 PERI-IMPLANTITIS. TOOTH #19.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14373245 ↗