OSSEOTITE® CERTAIN® PREVAIL XIITP5415Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00844868022183), received between Dec 20, 2019 and Dec 20, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 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 #21, #23, AND #27 WERE REMOVED DUE TO INFECTION. PATIENT PRESENTED WITH PAIN, AND SWELLING. SYMPTOMS AS A RESULT OF THE EVENT WAS ABSCESS.

  Patient problems: Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 23858508 ↗
• InjuryAug 27, 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 #6 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 22902283 ↗
• InjuryJun 4, 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 #12, 14, 15 WERE REMOVED DUE TO PERI IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19461721 ↗
• InjuryFeb 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 # 13 SHOWED PERI-IMPLANTITS AND WAS REMOVED. AT TORQUE TEST PATIENT HAD DISCOMFORT. NO MOBILITY NOTED SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18792164 ↗
• InjuryJul 26, 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 #11 WAS REMOVED DUE TO PAIN. (B)(6) 2023 IMPLANTS (B)(6) WERE PLACED FOR FIXED BRIDGE. ON 3/27, 2023 PATIENT COMPLAINED OF PAIN, IMPLANT #(B)(6) WAS REMOVED AND IMPLANT #12 PLACED. PATIENT STATED HE "CANT LIVE WITH SCREWS IN HEAD" REQUESTED IMPLANT TO BE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & HEADACHE. CUSTOMER CALLED BACK AND REPORTED THAT THE IMPLANT AT TOOTH #11 WAS XIITP5415 REMOVED ON (B)(6) 2023 DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 17402089 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION AND BONE LOSS WERE NOTED AROUND THE IMPLANT AT TOOTH LOCATION #29 ON THE FOLLOW UP EXAM. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA, INFLAMMATION AND PAIN.

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

  MAUDE report 16521710 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS ON TOOTH SITE #30 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 16138527 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CUSTOMER THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. BONE LOSS WAS REPORTED AS SYMPTOM. TOOTH # 6. THE SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15267456 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH LOCATIONS #19 AND #30 DID NOT INTEGRATE DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 14688582 ↗
• InjurySep 17, 2021Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation; Pain; Sinus Perforation

  MAUDE report 12490607 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (XIITP5415) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 5. GRANULATED TISSUE WAS REPORTED DURING POST-OP CHECK UP.

  Patient problems: Unspecified Infection

  MAUDE report 9764829 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Abscess; Inflammation; No Code Available; Unspecified Infection

  MAUDE report 9503898 ↗