OSSEOTITE® CERTAIN® PREVAIL XIITP5410Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00844868022152), received between Jan 3, 2020 and May 26, 2026 — classified as 87 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (11 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 94 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #2 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT FELL OUT AT DENTIST DURING CROWN SEATING.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25281073 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO BONE LOSS AND INFECTION. THE IMPLANT PLACEMENT WAS PERFORMED AFTER A SINUS-LIFT GRAFT IN (B)(6) 2024, THE IMPLANT WAS PUT INTO FUNCTION AT SIX MONTHS, AND BONE LOSS WITH INFECTION APPEARED ELEVEN MONTHS LATER. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 25231759 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO BONE LOSS. ON (B)(6) 2023 THE PATIENT SAT FOR A NEW PATIENT EXAMINATION. THE IMPLANT WAS EXTRACTED AND A BONE GRAFT AND A BARRIER WAS PLACED. AN INTERNAL SINUS LIFT WAS PERFORMED AND AN IMPLANT WAS PLACED. A STABILITY CHECK WAS PERFORMED ON (B)(6) 2024 AND THE SUITABILITY FOR IMPLANT RESTORATION WAS EVALUATED. ON (B)(6) 2026 THE SITE WAS EVALUATED AND REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 24988557 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 14 WAS REMOVED DUE TO PERI IMPLANTITIS. A NEW IMPLANT WILL BE PLACED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24685901 ↗
• MalfunctionMar 5, 2026Mechanical Problem

  DURING IMPLANT INSERTION, THE INTERNAL CONNECTION WAS DAMAGED AND CORRECT FINAL POSITIONING COULD NOT BE ACHIEVED. THE IMPLANT WAS REMOVED AND REPLACED WITH A NEW IMPLANT DURING THE SAME SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516789 ↗
• MalfunctionFeb 4, 2026Mechanical Problem

  THE DOCTOR REPORTS THAT DURING THE IMPLANT INSTALLATION, WHILE TIGHTENING WITH THE TORQUE WRENCH, THE INTERNAL CONNECTION WAS DAMAGED, THEREFORE THE IMPLANT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT. THE AFFECTED DENTAL POSITION WAS NUMBER 26, BONE TYPE NUMBER III.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256101 ↗
• InjuryAug 19, 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 #13 AND #14 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22842819 ↗
• InjuryAug 11, 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 REMOVED DUE TO INFECTION WHICH WAS DISCOVERED DURING TORQUE TESTING WHILE REMOVING A HEALING ABUTMENT. A PAN WAS TAKEN AND DARK RADIOLUCENCY WAS PRESENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22778721 ↗
• InjuryAug 1, 2025Adverse 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. UNKNOWN TOOTH SITE. PATIENT REFERRED PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22689282 ↗
• InjuryMar 26, 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: Osteolysis; Unspecified Infection

  MAUDE report 21696773 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION AT TOOTH SITE # 4. THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 21663982 ↗
• InjuryDec 14, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED MECHANICAL FAILURE OF IMPLANT #13, UNABLE TO RESTORE #13. PER INDICATED: SYMPTOMS AS A RESULT OF THE EVENT: NONE INDICATES. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NOT INDICATED. ADDITIONAL APPOINTMENT REQUIRED: NONE INDICATED. ON (B)(6) 2024 COMPLAINT COORDINATOR CALLED THE CUSTOMER AND CUSTOMER CONFIRM PLACEMENT DATE (B)(6) 2020, IMPLANT WAS REMOVED FOR INFECTION AND MECHANICAL FAILURE. ANTIBIOTICS WAS GIVEN FOR THE INFECTION. CUSTOMER COULD NOT CONFIRM IF THIS EVENT IS THE IMPLANT THAT WAS MANGLED (STATING MANGLED IMPLANT=MECHANICAL FAILURE).

  Patient problems: Unspecified Infection

  MAUDE report 20932520 ↗
• InjuryNov 27, 2024Adverse 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: Osteolysis

  MAUDE report 20794343 ↗
• InjuryNov 22, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AFTER SEVERAL ATTEMPTS TO PLACE A CROWN, IT WAS IMPOSSIBLE TO ADAPT ANY OF THEM TO THE IMPLAN. IT WAS DECIDED TO REMOVE THE IMPLANT AT TOOTH SITE 47 DUE TO IMPLANT DAMAGED CONNECTION. SITE WAS GRAFTED SIMOULTANIOUSLY TO IMPLANT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20755915 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 10 DAYS AFTER IMPLANT PLACEMENT PATIENT HAD AN ABSCESS. IMPLANT REMOVED DUE TO INFECTION. TOOTH LOCATION 16.

  Patient problems: Unspecified Infection

  MAUDE report 20693270 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT COMPLAINS OF PAIN. TISSUE AGGRAVATED PURLANCE BUMP ON BUCCAL WALL. PER INDICATED: SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, REMOVAL. WAS THERE A DELAY DURING THE PROCEDURE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES, REPLACEMENT. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO.

  Patient problems: Unspecified Infection

  MAUDE report 20650975 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BONE LOSS AROUND THE IMPLANTS THAT DR. (B)(6) PLACED. GENERAL DDS WANTED EVALUATED, UPON EVALUATION DISCUSSED REMOVAL AND REPLACEMENT FOR TOOTH # 29 AND 30. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, REMOVAL. ADDITIONAL APPOINTMENT REQUIRED: YES, TORQUE TEST. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Osteolysis

  MAUDE report 20650968 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. FISTULA IS REPORTED. A CULTURE WAS TAKEN, MUCO PERIOSTEAL FLAP WAS DONE, AREA WAS IRRIGATED WITH PERIDEX & WAS CLOSED UP. TOOTH SITE # 19. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20037637 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. FISTULA IS REPORTED. A CULTURE WAS TAKEN, MUCO PERIOSTEAL FLAP WAS DONE, AREA WAS IRRIGATED WITH PERIDEX & WAS CLOSED UP. TOOTH SITE # 20. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20037198 ↗
• InjuryJul 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Swelling/ Edema

  MAUDE report 19688418 ↗
• InjuryJun 28, 2024Adverse 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: Bone Fracture(s); Osteolysis

  MAUDE report 19634279 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED FOR TORQUE TEST AND FELT PAIN WHEN TORQUED. TOOTH #12. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain

  MAUDE report 19340541 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION AT TOOTH SITE #16. IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 18992399 ↗
• InjuryMar 15, 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 #14, WITH ASSOCIATED PAIN. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Pain

  MAUDE report 18909849 ↗
• InjuryFeb 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 # 7 CAME OUT ON ITS OWN DUE TO INFECTION. PATIENT PRESENTED WITH IMPLANT OUT OF HER MOUTH PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO . SYMPTOMS AS A RESULT OF THE EVENT: NONE.

  Patient problems: Unspecified Infection

  MAUDE report 18735691 ↗