OSSEOTITE® CERTAIN® XIFNT3210Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00844868021940), received between Jul 23, 2019 and Jun 11, 2026 — classified as 95 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK TO THE CLINIC DUE TO GUM RECESSION AND THREADS OF THE IMPLANTS SHOWING. THE IMPLANTS AT TOOTH SITES #6 AND #7 HAD SEVERE BONE LOSS AND WERE REMOVED AND BONE GRAFT WAS PLACED.

  Patient problems: Osteolysis

  MAUDE report 25477104 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 21 WAS REMOVED DUE TO AN INFECTION. THE PATIENT CAME TO THE EMERGENCY VISIT WITH TOOTH MOBILITY AND A SUPPURATING GUM. PATIENT SUFFERED FROM ABSCESS.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 25066512 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT(S) AT TOOTH SITE # 14+36 WERE REMOVED DUE TO A PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25065651 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT WAS REMOVED DUE TO A BONE LOSS AROUND THE IMPLANT WITH 4 TO 5 EXPOSED SUTURES. THE IMPLANT HAD BEEN UNSCREWED, WITH NO PAIN REPORTED. NO IMPACT ON THE PATIENT WAS REPORTED. BONE DENSITY TYPE: III.

  Patient problems: Osteolysis

  MAUDE report 25041416 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO BONE LOSS. THE IMPLANT WAS PLACED ON (B)(6) 2026. DURING AN UNCOVERING PROCEDURE, CRESTAL BONE LOSS WAS NOTED, BUT THE IMPLANT WAS INTEGRATED. IMPLANT WAS REMOVED AND THE SITE WAS GRAFTED AND ALLOWED TO HEAL FOR FUTURE IMPLANT REPLACEMENT.

  Patient problems: Osteolysis

  MAUDE report 24903396 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #28 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24557303 ↗
• InjuryJan 19, 2026Fracture

  IT WAS REPORTED THAT THE 2 IMPLANTS FRACTURED AND WERE REMOVED. TOOTH LOCATION 36 AND 37. NEW IMPLANTS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24107702 ↗
• InjuryJan 19, 2026Fracture

  IT WAS REPORTED THAT THE 2 IMPLANTS FRACTURED AND WERE REMOVED. TOOTH LOCATION 36 AND 37. NEW IMPLANTS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24107672 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #45 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24015469 ↗
• InjuryDec 22, 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 #7, AND #12 WERE REMOVED DUE TO INFECTION. PATIENT PRESENTED FOR FOLLOW UP DUE TO PAIN, PATIENT HAD INFECTION AND THE IMPLANTS WERE LOOSE. SYMPTOMS AS A RESULT OF THE EVENT WAS ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 23870312 ↗
• InjuryOct 28, 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 23404587 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN TOOTH SITE #16 FAILED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23357254 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND HIT THEIR FACE CAUSING THE IMPLANT AT TOOTH SITE #7 TO BECOME UNSTABLE. THE IMPLANT WAS REMOVED DUE TO TRAUMA. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Head Injury; Pain

  MAUDE report 22784646 ↗
• InjuryJun 14, 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 #31, #32, #42 WERE REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22208259 ↗
• InjuryJun 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE 34 AND THE IMPLANT WAS REMOVED. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22208215 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION OCCURRED IMMEDIATELY POST OPERATIVELY WITHIN THE FIRST WEEK OF SURGICAL PLACEMENT OF THE IMPLANT AT TOOTH SITE #12. ANTIBIOTICS WERE PRESCRIBED FOR TREATMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN, SWELLING.

  Patient problems: Unspecified Infection

  MAUDE report 22053685 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION OCCURRED IMMEDIATELY POST OP WITHIN THE FIRST WEEK OF SURGICAL PLACEMENT OF THE IMPLANT AT TOOTH SITE #12. THE INFECTION WAS UNRESPONSIVE TO ANTIBIOTIC TREATMENT AND THE IMPLANT FELL OUT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN, SWELLING.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 22053523 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 14 WAS REMOVED DUE TO PERI-IMPLANTITIS. EDEMA, INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 21888460 ↗
• InjuryApr 4, 2025Fracture; Fracture

  THE DOCTOR REPORTS THAT THE PATIENT ATTENDED A ROUTINE CHECK-UP FOR THEIR OVERDENTURE AND NOTICED THAT THE IMPLANT AT TOOTH SITE 13 HAD MOBILITY. UPON EXPLANTATION, IT WAS DETECTED THAT THE IMPLANT WAS FRACTURED, LEADING TO A FLAP SURGERY TO RETRIEVE THE REMAINING PART OF THE IMPLANT. THE PATIENT WILL RETURN IN THE FUTURE FOR THE PLACEMENT OF A NEW IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772597 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #8 SHOWED RADIOGRAPHIC RADIOLUCENCY INDICATING INFECTION. THE IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21644447 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK FOR POST OP AND THERE WAS FISTULA & INFECTION PRESENT AROUND THE IMPLANT AT TOOTH SITE #8. THE IMPLANT WAS REMOVED AND BONE GRAFT WAS PLACED.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 21457669 ↗
• InjuryFeb 10, 2025Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT A SINUS PERFORATION OCCURRED AFTER THE FIRST STAGE OF THE IMPLANT PLACEMENT AND THE IMPLANT WAS REMOVED. PROCEDURE NOT COMPLETED.

  Patient problems: Sinus Perforation

  MAUDE report 21341951 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS ATTEMPTING TO HELP A YOUNG PERSON WHO HAD SEVERE RESORPTION FROM ORTHO. THE IMPLANT AT TOOTH LOCATION #7 WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060562 ↗
• InjuryNov 29, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808881 ↗
• InjuryNov 11, 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: Inflammation

  MAUDE report 20651242 ↗