OSSEOTITE® CERTAIN® PREVAIL XIITP6513Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00844868022220), received between Oct 8, 2019 and Aug 8, 2025 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2025Adverse 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: Discomfort; Pain

  MAUDE report 22748576 ↗
• InjuryJun 23, 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 #47 AND #37 WERE REMOVED DUE TO ALLERGIC REACTION AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.

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

  MAUDE report 22306595 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A LOOSE IMPLANT AT TOOTH LOCATION #30. THE IMPLANT WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21652320 ↗
• InjuryOct 8, 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 #19 WAS REMOVED DUE TO BONE LOSS. IMPLANT WAS PLACED 2 YEARS AGO BUT NEVER RESTORED BY DENTIST BECAUSE OF BUCCAL BONE LOSS. WE DECIDED TO REMOVE THE IMPLANT, GRAFT THE SITE AND HAD THE PATIENT RETURN IN 3 MONTHS FOR A NEW IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 20397400 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIODONTAL DISEASE NOTED AT IMPLANT SITE. IMPLANT WAS REMOVED PER TREATMENT PLAN.

  Patient problems: Osteolysis

  MAUDE report 19985350 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BONE LOSS AT IMPLANT TOOTH SITE #30. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 18909750 ↗
• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #14. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 18417051 ↗
• InjuryNov 10, 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 INFECTION. SITE GRAFTED: NO. IMPLANT SITE: 31.

  Patient problems: Unspecified Infection

  MAUDE report 18116401 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PANORAMIC REVEALED THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #13, WITH ASSOCIATED PAIN TO THE TOUCH. THEREFORE, THE IMPLANT WAS REMOVED, AND BONE GRAFTED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17964107 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 36 WAS REMOVED DUE TO PERI-IMPLANTITIS. AFTER IMPLANT PLACEMENT THERE WAS A CORONAL BONE LOSS OF 50%. PATIENT WAS RESCHEDULED FOR NEW IMPLANT PLACEMENT AT A LATER DATE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17548273 ↗
• InjuryAug 10, 2023Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis; Unspecified Infection

  MAUDE report 17498561 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE ONE-MONTH POST-OP VISIT, 4MM BUCCAL BONE LOSS WAS OBSERVED AT TOOTH SITE # 30. THE IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 17378552 ↗
• MalfunctionMay 27, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT BECAME STRIPPED DURING PLACEMENT. PROCEDURE WAS COMPLETED USING A LARGER IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 14526209 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #UNK WERE REMOVED DUE TO LACK OF PRIMARY STABILITY. IMPLANT WAS A SPINNER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591429 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 12124692 ↗
• InjuryFeb 4, 2021Adverse 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 LACK OF PRIMARY STABILITY. THE PROCEDURE WAS NOT COMPLETED AND THE SITE WAS GRAFTED. TOOTH SITE UNKNOWN.

  Patient problems: No Information

  MAUDE report 11281934 ↗
• InjuryNov 19, 2020Adverse 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 INFECTION AT TOOTH LOCATION 19.

  Patient problems: Unspecified Infection

  MAUDE report 10869490 ↗
• InjuryJul 17, 2020Adverse 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 NO PRIMARY STABILITY IN TOOTH SITE # 32.

  Patient problems: No Information

  MAUDE report 10290032 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PRIMARY STABILITY WAS NOT ACHIEVED WITH IMPLANT XIITP6513 IN TOOTH SITE #31.

  Patient problems: No Information

  MAUDE report 9917851 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PRIMARY STABILITY WAS NOT ACHIEVED WITH IMPLANT XIITP6513. PATIENT WAS GRAFTED AND SENT HOME TO HEAL. TOOTH SITE #19.

  Patient problems: No Information

  MAUDE report 9398204 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PRIMARY STABILITY WAS NOT ACHIEVED WITH IMPLANT XIITP6513 IN SITE #4. THE SITE WAS BONE GRAFTED AND SENT HOME TO HEAL.

  Patient problems: No Information

  MAUDE report 9262264 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PATIENT PRESENTED WITH INFECTION AROUND IMPLANT XIITP6513. ABSCESS WAS ALSO REPORTED AND IMPLANT WAS REMOVED. TOOTH SITE IS #18.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 9166338 ↗