OSSEOTITE® CERTAIN® PREVAIL XIITP4310Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 4/3 X 10MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN PREVAIL (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a ZimVie Osseotite Tapered Certain Prevail dental implant, a root-form screw placed in the jaw to replace a tooth. The 71 reports mostly describe implants that failed to fuse with the bone or later became infected, with ongoing bone loss, pain, inflammation and pus at the site, so the implant had to be removed. There were69 injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 69
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00844868022114), received between Jun 10, 2019 and May 14, 2026 — classified as 69 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem67
- Separation Failure2
- Detachment of Device or Device Component1
- Loss of Osseointegration1
- Mechanical Problem1
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection45
- Osteolysis33
- Pain19
- Inflammation6
- No Information6
- Abscess5
- No Clinical Signs, Symptoms or Conditions5
- No Code Available5
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25173257 ↗InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO BONE LOSS AND INFECTION. THE IMPLANT WAS NOTED TO HAVE CHRONIC INFLAMMATION WITH RADIOGRAPHIC EVIDENCE OF PROGRESSIVE BONE LOSS. THERE WAS INFLAMMATION AND INFECTION AROUND THE IMPLANT. IMPLANT WAS REMOVED. BONE REGENERATION WAS PERFORMED & IMPLANT WAS REPLACED.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24847376 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 24673255 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 24468236 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 24468209 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. POST OP VISIT 1 MONTH AFTER IMPLANT PLACEMENT, ABSCESS, TENDERNESS, PUS WHEN PROBING. TOOTH #'S 19. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 24468188 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #20 AND #21 WERE REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24460733 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 24307261 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO PERI-IMPLANTITIS. ADDITIONAL APPOINTMENT REQUIRED FOR REPLACEMENT OF #12 IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24053209 ↗InjuryNov 18, 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 #8 WAS REMOVED DUE TO PERI-IMPLANTITIS. MOBILE. FAILED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23589909 ↗MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23448333 ↗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 22842719 ↗InjuryJul 31, 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 #21 TORQUED, BUT RADIOLUCENCY WAS PRESENT. CBCT SHOWS POSSIBLE OSTEOMYELITIS IN THE LOWER JAW. THE IMPLANT WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 22680699 ↗InjuryJun 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 #13 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT'S IMPLANT SITE #13 HAD DRAINAGE. PATIENT TAKING PBX UPON TESTING FOR TORQUE VALUE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 22238503 ↗InjuryMar 18, 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 #4 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Unspecified Infection
MAUDE report 21633816 ↗InjuryJan 7, 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 NUMBER 13 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21096367 ↗InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS MOBILE AND WAS REMOVED DUE TO PERIIMPLANTITIS. PROCEDURE WAS NOT COMPLETED. ADDITIONAL APPOINTMENT IS REQUIRED TO PLACE NEW IMPLANT AND BONE GRAFT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20923717 ↗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 20650966 ↗InjurySep 18, 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: Inflammation; Pain; Unspecified Infection
MAUDE report 20246081 ↗InjurySep 18, 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: Inflammation; Pain
MAUDE report 20245522 ↗InjuryJul 22, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 25 WAS REMOVED DUE TO BONE LOSS, INFECTION AND ALLERGIC REACTION.
Patient problems: Hypersensitivity/Allergic reaction; Osteolysis; Unspecified Infection
MAUDE report 19790742 ↗InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT PRESENTS W/INFECTION AROUND IMPLANT # 8 REQUIRING REMOVAL.
Patient problems: Unspecified Infection
MAUDE report 19763991 ↗InjuryJul 15, 2024Adverse 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. TOOTH # 3.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19742708 ↗InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PERI-IMPLANTITIS WAS REPORTED AND THE IMPLANT WAS REMOVED. TOOTH #5.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19382905 ↗InjuryApr 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE #3 AND #4 WERE REMOVED DUE TO NEUROLOGICAL PROBLEMS.
Patient problems: Nerve Damage
MAUDE report 19057161 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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