OSSEOTITE® CERTAIN® PREVAIL XIITP4313Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00844868022138), received between Jan 8, 2020 and Sep 28, 2026 — classified as 86 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 89 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the implant at tooth site 21 was removed due to peri-implantitis. When switching cover screw for and encode healing abutment, infection was noticed and implant was loose. Patient had previous infection on the site which it was clean and treated but due to patient medical condition with low platelets counts, the infection came back and 2 implants had to be removed.This event refers to the peri-implantitis in tooth site 21.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50913977 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implants at tooth sites 22 (XIITP4313) and 23 (XIFNT513) were removed due to periimplantitis.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50066710 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 4 WAS REMOVED DUE TO INFECTION & BONE LOSS. IMPLANT PLACE (B)(6) 2026 SUTURE REMOVAL (B)(6) 2026 PATIENT RETURNED ON 5/20/26 WITH PAIN AND EXAM REVEALED GINGIVAL SWELLING. IMPLANT WAS UNCOVERED AND NOTED TO HAVE BONE LOSS AND WAS LOOSE. IMPLANT WAS REMOVED AND OSTEOTOMY DEBRIDED. SYMPTOMS / PATIENT IMPACT: EDEMA, INFLAMMATION, SWELLING.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25473872 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO (2) IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PATIENT WILL RETURN TO HAVE IMPLANTS REPLACED. TOOTH LOCATIONS WERE NOT PROVIDED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25399467 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO THE CLINIC WITH SWELLING AND PAIN AT THE MANDIBULAR RIGHT SIDE. THE IMPLANT AT TOOTH SITE #29 WAS INFECTED. THE IMPLANT WAS REMOVED AND INCISION WITH DRAINAGE WAS PERFORMED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 25284240 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #22 WAS REMOVED DUE TO BONE LOSS AND INFECTION. AN ABSCESS DEVELOPED ONE MONTH AFTER THE PROCEDURE, WITH PAIN, SWELLING, AND IMPLANT MOBILITY DESPITE GOOD INITIAL STABILITY. THE IMPLANT WAS REPLACED IN (B)(6) 2025 AND LATER PUT BACK INTO FUNCTION IN (B)(6) 2026.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25232231 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 12 WAS REMOVED DUE TO A BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 24965610 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 3 WAS REMOVED DUE TO PERI IMPLANTITIS. A NEW IMPLANT WILL BE PLACED WITH BONE GRAFT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24685944 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24668917 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 WAS REMOVED DUE TO INFECTION. PATIENT CAME IN FOR POSTOPERATIVE EVALUATION AFTER EXPERIENCING SWELLING AND INCREASED PAIN WITH MANDIBLE AREA. CBCT WAS TAKEN AND EXTENSIVE INFECTION WAS NOTED AROUND ALL ANTERIOR MANDIBLE AFFECTING IMPLANT. PATIENT WAS SCHEDULED FOR REMOVAL OF IMPLANT THE NEXT DAY AND CULTURES WERE TAKEN. PROCEDURE WAS NOT COMPLETED USING ANOTHER IMPLANT, SITE WILL BE ALLOWED TO HEAL NATURALLY. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN & SWELLING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24072830 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24072809 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24072808 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 WAS REMOVED DUE TO INFECTION. PATIENT CAME IN FOR POSTOPERATIVE EVALUATION AFTER EXPERIENCING SWELLING AND INCREASED PAIN WITH MANDIBLE AREA. CBCT WAS TAKEN AND EXTENSIVE INFECTION WAS NOTED AROUND ALL ANTERIOR MANDIBLE AFFECTING IMPLANT. PATIENT WAS SCHEDULED FOR REMOVAL OF IMPLANT THE NEXT DAY AND CULTURES WERE TAKEN. PROCEDURE WAS NOT COMPLETED USING ANOTHER IMPLANT, SITE WILL BE ALLOWED TO HEAL NATURALLY. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN & SWELLING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24072807 ↗
• InjuryJan 13, 2026Moisture Damage

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #21 WAS REMOVED DUE TO BONE LOSS. THE PATIENT HAD ONE LOST FACIAL WHICH REQUIRED IT'S REMOVAL. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO UNCOVER THE NEW IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 24057669 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN FOR THREE-MONTH FOLLOW-UP AFTER IMPLANT PLACEMENT. PATIENT HAD FISTULA WITH INFECTION ASSOCIATED TO SITE #15. REMOVED IMPLANT AND GRAFTED SOCKET. WILL RETRY PLACEMENT IN FOUR MONTHS.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 23761009 ↗
• InjurySep 3, 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: Hypersensitivity/Allergic reaction; Inflammation; Unspecified Infection

  MAUDE report 22956351 ↗
• InjurySep 3, 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: Hypersensitivity/Allergic reaction; Inflammation; Unspecified Infection

  MAUDE report 22955523 ↗
• InjuryMay 24, 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 11 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND EDEMA.

  Patient problems: Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 22081965 ↗
• InjuryMay 8, 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 #3, #5, #7, #9, #12, #13 AND #14 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21984025 ↗
• InjuryMay 8, 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 #3, #5, #7, #9, #12, #13 AND #14 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21983650 ↗
• InjuryMay 8, 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 #3, #5, #7, #9, #12, #13 AND #14 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21983579 ↗
• InjuryMay 2, 2025Mechanical 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 21951791 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PATIENT PRESENTS WITH NECROTIC BONE, PURULENCE, REDNESS AND SWELLING, TOOTH 19. I&D (INCISION AND DRAINAGE) EXTERNAL CHON DRAIN PLACED AND REMOVAL OF IMPLANT SITE #19 AND DEBRIDEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION. ADDITIONAL APPOINTMENT REQUIRED: YES, POSSIBLE REPLACEMENT.

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 21884601 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21577535 ↗
• InjuryDec 6, 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 WAS REMOVED DUE TO PERI-IMPLANTITIS. TISSUE AROUND SURGICAL SITE WAS RED & INFLAMED & BONE WAS NOT FILLING IN AROUND THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20865674 ↗