OSSEOTITE® CERTAIN® PREVAIL XIITP5413Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00844868022176), received between Oct 8, 2019 and Sep 7, 2026 — classified as 46 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. 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 47 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50650946 ↗
• 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. BONE GRAFT WAS PLACED.

  Patient problems: Osteolysis

  MAUDE report 25476960 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RETURNS TO CLINIC WITH PAIN AT IMPLANT #5 SITE. RADIOGRAPHIC REVEALS IMPLANT INFECTED. IMPLANT REMOVED, SITE BONE GRAFTED AND WILL RETURN IN 4-6 MONTHS FOR IMPLANT REPLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 25105197 ↗
• InjuryDec 18, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838823 ↗
• MalfunctionJul 16, 2025Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22525898 ↗
• InjuryMar 18, 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 #13 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 21635160 ↗
• InjuryMar 18, 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 #28 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 21634360 ↗
• InjuryMar 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 #14 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND ABSCESS.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 21599269 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS GOING INTO DENTURES AND NEEDED THE IMPLANT AT TOOTH LOCATION #10 REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432273 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #22 AND #27 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20662194 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #22 AND #27 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20662192 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNCOVERING, IMPLANT THREADS BECAME VISIBLE. ATROPHY AROUND ALL IMPLANTS. TOOTH #'S 7, 10, 13, AND 27 (UNIVERSAL). THE IMPLANTS WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20641521 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNCOVERING, IMPLANT THREADS BECAME VISIBLE. ATROPHY AROUND ALL IMPLANTS. TOOTH #'S 7, 10, 13, AND 27 (UNIVERSAL). THE IMPLANTS WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20641515 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNCOVERING, IMPLANT THREADS BECAME VISIBLE. ATROPHY AROUND ALL IMPLANTS. TOOTH #'S 7, 10, 13, AND 27 (UNIVERSAL). THE IMPLANTS WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20641500 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNCOVERING, IMPLANT THREADS BECAME VISIBLE. ATROPHY AROUND ALL IMPLANTS. TOOTH #'S 7, 10, 13, AND 27 (UNIVERSAL). THE IMPLANTS WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20641448 ↗
• InjuryOct 29, 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 20557842 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION # 18 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 20039155 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FULL EXPOSURE OF THE DISTAL DUE TO BONE LOSS. TOOTH #6. THE IMPLANT WAS REMOVED.SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Osteolysis

  MAUDE report 18836557 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ACUTE SINUSITIS. TOOTH 14. IMPLANT WAS REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17741928 ↗
• InjurySep 1, 2023Adverse 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: Bacterial Infection

  MAUDE report 17670395 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES # 36 AND 34 WERE REMOVED DUE TO PERI-IMPLANTITIS. INFECTION AND BONE LOSS APPEARED AFTER. THE SITE WAS GRAFTED AND THE PATIENT WAS RESCHEDULED FOR NEW IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17514750 ↗
• 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 17395617 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED PAIN AND SWELLING AROUND THE IMPLANT AT TOOTH LOCATION #(B)(6). CLINICAL INFECTION WAS NOTED, AND THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN.

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

  MAUDE report 17066245 ↗
• InjuryApr 4, 2023Adverse 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. THE SITE WAS GRAFTED WITH ALLOGRAFT. INFLAMMATION AND PURULENCE ARE REPORTED SYMPTOMS.

  Patient problems: Inflammation; Osteolysis; Purulent Discharge; Unspecified Infection

  MAUDE report 16677514 ↗
• InjuryApr 4, 2023Adverse 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. THE SITE WAS GRAFTED WITH ALLOGRAFT. INFLAMMATION AND PURULENCE ARE REPORTED SYMPTOMS.

  Patient problems: Inflammation; Osteolysis; Purulent Discharge; Unspecified Infection

  MAUDE report 16676822 ↗