OSSEOTITE® CERTAIN® PREVAIL XIITP6510Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00844868022206), received between Oct 31, 2019 and Apr 8, 2026 — classified as 51 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 BECAME MOBILE AND WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND EDEMA.

  Patient problems: Abscess; Swelling/ Edema; Unspecified Infection

  MAUDE report 24815065 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO LACK OF PRIMARY STABILITY ASSOCIATED WITH INTERSEPTAL BONE FRACTURE. AN ADDITIONAL APPOINTMENT WAS ANTICIPATED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Bone Fracture(s); Erosion

  MAUDE report 23968044 ↗
• MalfunctionDec 9, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT HEX IS STRIPPED IN IMPLANT. PATIENT HAD CROWN PLACED IN 2025. PATIENT HAD PAIN AND CROWN WAS MOBILE. SCAN SHOWS IMPLANT IS HEALTHY AND STABLE. REMOVED CROWN AND TT IMPLANT STABLE. CROWN REPLACED AND WAS STILL MOBILE. IMPLANT REMOVED PLACED A NEW IMPLANT. TOOTH SITE: 31.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756406 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS SEVERE BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #19 REQUIRING REMOVAL WITH REPLACEMENT IN TOOTH SITE #20.

  Patient problems: Osteolysis

  MAUDE report 23605005 ↗
• InjuryNov 17, 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 MOBILE AND FAILED DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23569531 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING CONSISTENT HEADACHES. CBCT SHOWED THAT THE IMPLANT WAS IN THE SINUS CAVITY. THE IMPLANT WAS REMOVED DUE TO SINUS PERFORATION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, FACIAL SWELLING, AND INFLAMMATION.

  Patient problems: Osteolysis; Sinus Perforation; Swelling/ Edema

  MAUDE report 21378569 ↗
• InjuryDec 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL IMPLANT #3 PER PATIENT'S REQUEST DUE TO PATIENT HAVING HEADACHES. SYMPTOMS AS A RESULT OF THE EVENT: PAIN HEADACHES. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NOT INDICATED. ADDITIONAL APPOINTMENT REQUIRED: NONE INDICATED. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE? NOT REPORTED.

  Patient problems: Headache; Pain

  MAUDE report 20932503 ↗
• InjuryNov 18, 2024Adverse 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: Necrosis; Osteolysis

  MAUDE report 20714940 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPON UNCOVERING, BUCCAL BONE LOSS WAS PRESENT. THE IMPLANT WAS REMOVED. TOOTH #30 (UNIVERSAL).

  Patient problems: Osteolysis

  MAUDE report 20641412 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN AT THE OFFICE AND INFECTION WAS NOTED AROUND THE IMPLANT AT TOOTH LOCATION #14. THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 20513269 ↗
• InjuryOct 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 SITE #14 WAS REMOVED DUE PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20464463 ↗
• InjuryAug 23, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE HEX OF THE IMPLANT AT TOOTH LOCATION #30 WAS STRIPPED AND THEY COULD NOT PROPERLY SEAT THE HEALING CAPS. THE IMPLANT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055640 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH CONCERNS ABOUT LOOSE IMPLANT. IMPLANT HAD PERI IMPLANTITIS NOTED BONE LOSS. THEY REPLACED IMPLANT WITH A LARGER IMPLANT. SITE WAS GRAFTED TOGETHER WITH IMPLANT PLACEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19611638 ↗
• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE # 14 FELL OUT AFTER THE PT HAD AN ACCIDENT AND FELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19412386 ↗
• InjuryMay 15, 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 #30 WAS REMOVED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 19326076 ↗
• InjuryApr 13, 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, WITH ASSOCIATED INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 19102558 ↗
• InjuryApr 1, 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 #14 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 19013548 ↗
• InjuryNov 20, 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. PLACED ALLOGRAFT. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS, PERI-IMPLANTITIS, PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18176302 ↗
• InjurySep 22, 2023Fracture; Fracture

  NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation

  MAUDE report 17804838 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER INDICATED: IMPLANT INTO LEFT MAXILLARY SINUS. SITE 14 GRAFTED WITH ALLOGRAFT ON (B)(6) 2023. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: IMPLANT REMOVED. ADDITIONAL APPOINTMENT REQUIRED: YES, TO REPLACE IMPLANT. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE? NO.

  Patient problems: Sinus Perforation

  MAUDE report 17256164 ↗
• 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 16677461 ↗
• 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 16676807 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH # 30 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16482183 ↗
• InjuryJan 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 LOCATION #18 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PARAESTHESIA AND PAIN.

  Patient problems: Inflammation; Pain; Paresthesia; Unspecified Infection

  MAUDE report 16225367 ↗
• MalfunctionDec 21, 2022Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED IMPLANT STRIPPED. TOOTH 18 (UNIVERSAL). PLACED DIFFERENT IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16026114 ↗