OSSEOTITE® CERTAIN® XIFNT3213Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00844868021902), received between Sep 27, 2019 and Jun 9, 2026 — classified as 69 injuries, 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #32 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 25447499 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #22 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS LOST DUE TO MOBILITY, INFECTION, AND SEVERE BONE LOSS, WHICH DID NOT ALLOW THE PLACEMENT OF A NEW IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 25190826 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #9 WAS REMOVED DUE TO BONE LOSS. THE CUSTOMER REQUESTED A REIMBURSEMENT FOR THE SAME IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 24628343 ↗
• InjuryFeb 19, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR UN-COVERY OF A DIFFERENT IMPLANT. THE PATIENT WAS HAVING PAIN WITH THE IMPLANT AT TOOTH SITE #6. THE IMPLANT WAS LOOSE AND ONCE REMOVED AND AN X-RAY WAS TAKEN, WE DISCOVERED THAT THE IMPLANT HAD FRACTURED. BONE LOSS WAS ALSO REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 24394494 ↗
• InjuryOct 21, 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 INFECTION. PATIENT PRESENTED WITH SWELLING AND PAIN. AFTER DOING C-EXAM, IMPLANT APPEARED TO BE INFECTED, REMOVED IMPLANT SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: IMPLANT WAS REMOVED. TOOTH SITE: 6. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 23354527 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR SECOND STAGE SURGERY AND UPON INVESTIGATION, THE IMPLANTS AT TOOTH SITES #22 AND #27 WERE UNSTABLE. THE IMPLANTS WERE EXTRACTED OUT WITH FORCEPS DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23350667 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR SECOND STAGE SURGERY AND UPON INVESTIGATION, THE IMPLANTS AT TOOTH SITES #22 AND #27 WERE UNSTABLE. THE IMPLANTS WERE EXTRACTED OUT WITH FORCEPS DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23350553 ↗
• MalfunctionMay 16, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034786 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH LOCATION #19 WAS MOBILE AND WAS REMOVED DUE TO PERIIMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21944564 ↗
• InjuryApr 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 #26 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21914256 ↗
• InjuryMar 3, 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 BONE LOSS. CUSTOMER REPORTED LOOKED GREAT AT 2 WEEK FOLLOW UP, PATIENT REPORTED FOR 4 MONTH FOLLOW UP WITH BONE LOSS. TOOTH 6. IMPLANT REMOVED; SITE GRAFTED.

  Patient problems: Osteolysis

  MAUDE report 21510075 ↗
• InjuryJan 9, 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 #8 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND SWELLING.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 21115981 ↗
• InjuryDec 27, 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 #10 WAS REMOVED DUE TO BONE LOSS & INFECTION. PATIENT COMPLAINED OF PAIN, REMOVED CROWN, IMPLANT REMOVED PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN & SWELLING.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 21026034 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 34 WAS REMOVED DUE TO BONE LOSS DUE TO TRANSVERSAL CLENCHING.

  Patient problems: Osteolysis

  MAUDE report 20816703 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #12. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20794234 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS SWOLLEN, HAD PAIN, AND PURULENCE PRESENT AT SITE NUMBER 8 (UNIVERSAL). THE IMPLANT WAS REMOVED DUE TO INFECTION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20641535 ↗
• InjuryOct 2, 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 #15 WAS REMOVED DUE TO PERI IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20349959 ↗
• InjuryAug 12, 2024Adverse 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: Unspecified Infection

  MAUDE report 19961430 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WENT TO DENTIST OFFICE BECAUSE OF IMPLANT MOBILITY AND INFECTION. DENTIST REPORTED A PERIIMPLANTITIS AT TOOTH SITE # 33 - # 43. IMPLANTS WERE REMOVED. BONE TYPE: II.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19927873 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMES INTO CLINIC WITH PAIN AND INFLAMMATION IN TOOTH SITE #34, AT THE MOMENT OF REMOVING THE CROWN IT IS NOTED THAT THERE IS MOBILITY AND BONE LOSS, IMPLANT IS THEN REMOVED DUE TO PERIIMPLANTITIS, CURETTAGE PERFORMED ON EXTRACTION SITE. ADDITIONAL APPOINTMENT REQUIRED: YES, NEW IMPLANT WILL BE PLACED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19715237 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER 14 & 16 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. THE DOCTOR REPORTED : PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19356913 ↗
• InjuryApr 18, 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 #24(UNIVERSAL) WAS REMOVED DUE TO PERIIMPLANTITIS. SOFT TISSUE LOSS AROUND IMPLANT #24, MINOR REDNESS AND EXPOSED THREADS NOTED, PATIENT WAS SYMPTOMATIC. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, REDNESS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19132418 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANTS TOOTH SITES #24 AND 26, WITH ASSOCIATED ABSCESS, PAIN AND INFLAMMATION. THEREFORE, THE IMPLANTS WERE REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18862623 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANTS TOOTH SITES #24 AND 26, WITH ASSOCIATED ABSCESS, PAIN AND INFLAMMATION. THEREFORE, THE IMPLANTS WERE REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18862615 ↗
• InjuryFeb 19, 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 # 24 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18731564 ↗