OSSEOTITE® CERTAIN® PREVAIL XIITP4385Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00844868022107), received between Sep 20, 2019 and Jun 11, 2026 — classified as 27 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 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 IMPLANT WAS REMOVED DUE TO BONE LOSS. BUCCAL BONE GRAFTING DID NOT ADHERE TO LOSS OF BONE AROUND IMPLANT #29 (4.3 X 8.5). REMOVED IMPLANT AND PLACED NEW 4/3 X 8.5MM IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 25478103 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #34 AND #36 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 24524300 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #34 AND #36 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 24524211 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT UNDERWENT NEW CBCT IMAGING FOUR MONTHS AFTER IMPLANT PLACEMENT AT TOOTH SITE #20. CBCT IMAGING SHOWED BONE LOSS AROUND THE IMPLANT. CLINICAL EXAM REVEALED THAT THE IMPLANT WAS NOT VISIBLE IN THE ORAL CAVITY. CLINICIAN STATED THE IMPLANT WOULD NEED TO BE REMOVED. ON (B)(6) "205" THE IMPLANT WAS NOT EXPOSED AT THE START OF THE PROCEDURE. CLINICIAN EXPOSED IT, USED TREPHINE DRILL SLIGHTLY LARGER THAT THE IMPLANT AROUND ABOUT 3MM DOWN UNDER CORPUS IRRIGATION. REMOVED THE COVER SCREW AND BACKED OUT THE IMPLANT WITH CORRECT DRIVER. USED ROUNDED BUR TO STIMULATE BLEEDING. ALLOGRAFT WAS HYDRATED AND GORE-TEX MEMBRANE USED WITH GLYCOLON SUTURE.

  Patient problems: Osteolysis

  MAUDE report 23649567 ↗
• InjurySep 15, 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; Pain

  MAUDE report 23050964 ↗
• InjuryAug 1, 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. PER INDICATED: MOBILE, FAILED. PATIENTS GENERAL DENTIST REMOVED IT AND DISPOSED OF IMPLANT. TOOTH SITE: 19.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22686883 ↗
• InjuryJun 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 #33 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS MOBILE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22353051 ↗
• InjuryMay 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 #29 AND #30 WERE REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22081051 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED SITE ISSUES AND HIGH BLOOD GLUCOSE. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 400 MG/DL. THE CUSTOMER REPORTED HEMORRHAGE/BLEEDING, HYPOGLYCEMIA TREATED WITH NO TREATMENT, AND GLUCOSE/CARB INTAKE, RESPECTIVELY. THE EVENT INVOLVED PRODUCT(S) MMT-1884, MMT-332A, UNOMED INF SET, MMT-7040A. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. THE CUSTOMER WAS NOT USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT. THE CUSTOMER WAS REPORTING THE SENSOR LINER STAYED ON THE BASE WHILE PULLING THE SENSOR SERTER OFF. THE CUSTOMER REPORTED BLOOD AT THE SITE. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A. NO PRODUCT RETURN IS REQUIRED FOR MMT-397A.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21099916 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 47 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20564971 ↗
• InjuryJul 24, 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 # 12 & #13 WERE REMOVED DUE TO INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & INFLAMMATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19822216 ↗
• InjuryJul 16, 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 #5 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 19750214 ↗
• InjuryJun 19, 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 #4 WAS REMOVED DUE TO INFECTION. PATIENT PRESENTS S/P 4 WEEKS F/UNCOVER WITH PAIN. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19568136 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLACEMENT OF AN XIITP4385 IMPLANT IN TOOTH#16 IN (B)(6) 2023. PLACEMENT OF THE ABUTMENT IN (B)(6) 2023. PERIIMPLANTITIS WAS OBSERVED IN 2024, SO THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19367945 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #7, WITH ASSOCIATED PAIN. THE IMPLANT WAS REMOVED AND REPLACED AS RECOMMENDED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17746214 ↗
• 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 17396057 ↗
• 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 17395670 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE TISSUE AROUND THE IMPLANT AT TOOTH LOCATION #15 NEVER HEALED WELL AND NEEDED TO BE REMOVED. ALSO TO HELP PROTECT #14 IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 16811641 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED TO RETRACT THE INITIAL REPORT, MFR REPORT NUMBER 0001038806-2023-00567 AS THIS EVENT HAS ALREADY BEEN SUBMITTED AND IS A DUPLICATE OF MFR REPORT NUMBER 0001038806-2023-00563 THAT WAS SUBMITTED ON MARCH 23, 2023.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 16609868 ↗
• InjuryMar 23, 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 #15 WAS REMOVED DUE TO AN INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 16600934 ↗
• InjuryOct 15, 2021Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638594 ↗
• InjuryApr 28, 2021Adverse 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; Osteolysis; Pain; Unspecified Infection

  MAUDE report 11741202 ↗
• InjuryDec 16, 2020Adverse 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 AT TOOTH LOCATION 3. AS A RESULT, IMPLANT LOSS INTEGRATION AND IT WAS REMOVED; SITE WAS GRAFTED. INFLAMMATION AND PAIN WERE ALSO NOTED.

  Patient problems: Inadequate Osseointegration; Inflammation; Pain; Unspecified Infection

  MAUDE report 11020357 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT XIITP4385 IN DENTAL SITE 3 LACKED PRIMARY STABILITY. IT IS UNKNOWN IF DOCTOR WAS ABLE TO PLACE ANOTHER IMPLANT.

  Patient problems: No Information

  MAUDE report 9871289 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS LACK OF PRIMARY STABILITY COULD NOT BE ACHIEVED WITH IMPLANT XIITP4385.

  Patient problems: No Information

  MAUDE report 9566893 ↗