OSSEOTITE® CERTAIN® XIFNT510Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00844868022008), received between Jan 8, 2020 and Aug 22, 2026 — classified as 87 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 88 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to loss of integration and a peri-implantitis. Tooth site 37. Treatment included antibiotics, removal, curettage, and collagen bone grafting. Patient suffered from abscess, inflammation and pain.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50387066 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant was removed due to peri implantitis, tooth site 19.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50152631 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth #14 exfoliated spontaneously due to bone loss.

  Patient problems: Osteolysis

  MAUDE report 50033767 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #17 WAS REMOVED DUE TO AN INFECTION.THE DOCTOR REPORTED THAT THERE WAS A PAIN DURING THE IMPRESSION TAKING (THE IMPLANT CAME OUT WITH THE IMPRESSION TRANSFER).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24963840 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO AN INFECTION AND BONE LOSS. THE DOCTOR REPORTED THAT THERE WAS A SEVERE INFECTION OF THE IMPLANT SITE WITH SIGNIFICANT BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24963563 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLINICIAN DISCOVERED DURING CLINICAL PROCEDURE, LINGUAL BONE PERFORATION. WHEN PLACING, LINGUAL BONE WAS PERFORATED. BONE GRAFTING COMPLETED INSTEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 24634595 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #16 AND #46 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24535949 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24215025 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #36. IMPLANT WAS REMOVED. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23736340 ↗
• 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 23720223 ↗
• InjuryNov 12, 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. BONE LOSS, INFECTION, LOOSENING, ALSO REPORTED. PATIENT HAD RECURRENT EXACERBATIONS OF LOCALIZED MODERATE TO SEVERE PERIODONTAL ATTACHMENT LOSS INT THE #30 AREA OVER A 15+ PERIOD DESPITE REGULAR MAINTENANCE INTERVALS AND PERIODONTAL REGENERATIVE SURGERY. TOOTH #30 WAS EXTRACTED IN (B)(6) 2022 WITH BONE ALLOGRAFT (PUROS PARTICULATE) AND PTFE BARRIER PLACED. SEVEN MONTHS LATER A BIOMET3I CERTAIN IMPLANT WAS RIGIDLY PLACED IN A TAPPED SITE. APPROXIMATELY 3 YEARS LATER, THE RESTORED IMPLANT DEVELOPED PERI-IMPLANTITIS AND BECAME MOBILE. DEEP BONE DEFECTS DEVELOPED ON OPPOSITE SIDES OF THE TOOTH AND IMPLANT. THE PROBLEM WAS RECURRENT PERIODONTAL DISEASE. SALIVARY SAMPLES TAKEN WHEN #30 WAS PRESENT SHOWED THE PRESENCE OF 2 HIGH RISK PATHOGENS AND 3 MODERATE RISK PATHOGENS. ANTIBIOTICS WERE PRESCRIBED. THE #30 IMPLANT WAS REMOVED AND BONE GRAFTING PLUS A BARRIER WERE EMPLOYED TO MINIMIZE PONTIC SIZE FOR THE PLANNED TOOTH-BORNE FIXED BRIDGE. PATIENT TO RETURN FOR REMOVAL OF THE PTFE BARRIER AND POST-SURGICAL FOLLOW-UP IS PENDING. PROCEDURE COMPLETED USING ANOTHER IMPLANT BECAUSE SEVERAL MONTHS OF BONE HEALING MUST PASS PRIOR

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23533363 ↗
• InjuryOct 30, 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 PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT ARE INFLAMMATION, AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23427526 ↗
• InjuryJul 13, 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 AN ALLERGIC REACTION, PERI-IMPLANTITIS AND CHRONIC SYMPTOMS.

  Patient problems: Hypersensitivity/Allergic reaction; Osteolysis; Unspecified Infection

  MAUDE report 22490827 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR INFECTION, WHICH WAS DRAINING AROUND THE IMPLANT AT TOOTH SITE #19. THE CLINICIAN CLEANED AROUND THE IMPLANT WITH STERILE WATER AND PERIOGARD CEPHALEXIN ANTIBIOTICS TO RESOLVE THE ISSUE. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, PAIN ABSCESS, AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 22485432 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SMELL AND PAIN WHEN BRUSHING AND APPLYING PRESSURE AT TOOTH SITE #19. THE CLINICIAN OPTED TO REPLACE THE ENCODE AND A PRESCRIPTION OF Z-PACK ANTIBIOTICS WAS ISSUED TO RESOLVE THE SMELL AND PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22484852 ↗
• 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 22411159 ↗
• 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 22411006 ↗
• InjuryJun 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 SITE #19 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, SWELLING, PAIN ABSCESS, AND INFLAMMATION.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 22293033 ↗
• InjuryMay 31, 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 #14 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 22120461 ↗
• InjuryMay 22, 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 #30 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22069128 ↗
• InjuryMay 15, 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 # 26 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22025705 ↗
• 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 21983147 ↗
• InjuryMay 7, 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 #20 WAS REMOVED DUE TO BONE LOSS. PATIENT REPORTED TO OFFICE ONE YEAR AFTER SURGERY WITH EXTENSIVE BONE LOSS AT APEX OF IMPLANT AND MOBILITY. WE REMOVED THE IMPLANT AND REPLACED IT AT THE SAME SURGERY. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 21980535 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO PERI IMPLANTITIS. TOOTH LOCATION 26. BONE TYPE II.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21750225 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED AT THEIR 3 MONTHS POST SURGERY APPOINTMENT, THE IMPLANT AT TOOTH SITE #19 WAS LOOSE & NOT INTEGRATED. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA & INFLAMMATION.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 21349571 ↗