OSSEOTITE® CERTAIN® PREVAIL XIITP5411Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 5/4 X 11.5MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN PREVAIL (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Osseotite Prevail dental implant is a small screw-shaped root implant used to anchor a replacement tooth. The 55 reports mostly describe implants that had to be taken back out after infections around the implant site, bone loss, swelling and pain, sometimes with an abscess forming a month or more later. There were 52 injuries and no deaths. Most reports name no specific device or use problem, with only a few noting parts loosening or separating. 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
- 57
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00844868022169), received between Mar 2, 2020 and Jul 28, 2026 — classified as 54 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem51
- Mechanical Problem4
- Device Damaged by Another Device1
- Separation Failure1
Patient problems
- Unspecified Infection31
- Osteolysis24
- No Clinical Signs, Symptoms or Conditions9
- Pain8
- Inflammation7
- No Code Available6
- Abscess3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2026Device Damaged by Another Device
It was reported that the implant was internally stripped and was removed. Tooth site 30.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054791 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth #4 was removed due to bone loss during the patient¿s conversion to a maxillary DIEM.
Patient problems: Osteolysis
MAUDE report 50035195 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS AND INFECTION. THE IMPLANT PLACEMENT WAS SUCCESSFUL, WITH GOOD PRIMARY STABILITY, AND THE TOOTH ROOT WAS EXTRACTED ON THE SAME DAY. AN ABSCESS DEVELOPED ONE MONTH LATER.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 25232414 ↗MalfunctionMar 17, 2026Mechanical Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24614678 ↗InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 24490318 ↗InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. PER INDICATED: PAIN AT IMPLANT SITE, IMAGE SHOWED INFECTION. TOOTH SITE: 29. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 23956253 ↗InjuryDec 10, 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 #3 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23771121 ↗InjuryNov 14, 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort
MAUDE report 23559568 ↗InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO HAVE ABUTMENTS PLACED ON THE IMPLANTS AT TOOTH SITES #21 AND #23. IT WAS NOTED THAT THE TOOTH SITE #24 HAD CLASS THREE MOBILITY AND HAD A SINUS TRACT FROM THE APEX TO BETWEEN IMPLANTS #21 AND #23. THE IMPLANTS WERE REMOVED, AND THE ABUTMENTS WERE UNABLE TO BE REPLACED AS A RESULT. THE IMPLANTS REQUIRED REPLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 23529014 ↗InjuryNov 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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23495940 ↗InjuryMay 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 #13 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: FISTULA.
Patient problems: Fistula; Unspecified Infection
MAUDE report 22118619 ↗InjuryMay 28, 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 #29 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: SWELLING, ABSCESS AND PAIN.
Patient problems: Erosion; Swelling/ Edema; Unspecified Infection
MAUDE report 22101378 ↗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 21983464 ↗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 21983426 ↗InjuryMar 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 #15 WAS REMOVED DUE TO INFECTION AND SLIGHT BONE LOSS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21618712 ↗InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND SWELLING AT IMPLANT/CROWN. GENERAL DENTIST FOUND THAT CEMENT WAS POTENTIALLY HE CAUSE OF INFLAMMATION AND CAUSE OF IMPLANT FAILURE. PA CONFIRMED SMALL PIECES OF CEMENT LEFT UNDER CROWN AND AROUND IMPLANT/ABUTMENT. THE IMPLANT WAS REMOVED AND THE SITE WAS DEBRIDED AND GRAFTED. TOOTH SITE #30. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 19554464 ↗InjuryJun 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 #29 WAS REMOVED DUE TO BONE LOSS. PLACED BONE GRAFTING AND WAITING FOR BONE TO ADHERE BEFORE MOVING FORWARD.
Patient problems: Osteolysis
MAUDE report 19475513 ↗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 PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #6. BONE LOSS FOUND WITH PA TAKEN AT DENTAL OFFICE. PATIENT HAD UPPER HYBRID (8 IMPLANTS FOR MAXILLARY HYBRID DENTURE) OTHER 7 IMPLANTS STABLE 7 WNL, PATIENT WAS ASYMPTOMATIC. IMPLANT WAS PARTIALLY INTEGRATED, PUS PRESENT UPON INCISION. IMPLANT REMOVED DUE TO LOCALIZED BONE LOSS AND INFECTION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19102556 ↗InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BONE LOSS AND GRANULATION TISSUE PRESENT. PATIENT WAS HAVING SENSITIVITY ON UPPER LEFT, CAME IN TO SEE WHAT WAS GOING ON. TOOTH #12. WILL PLACE NEW IMPLANT AFTER SOCKET GRAFTING HEALS. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 19014381 ↗InjuryMar 14, 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 #29. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 18909740 ↗InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT REMOVED DUE TO INFECTION. GRAFTED. TOOTH #7.
Patient problems: Unspecified Infection
MAUDE report 18873587 ↗InjuryFeb 1, 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 #21. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 18628518 ↗InjuryJan 22, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED IMPLANT/ABUTMENT CONNECTION HAD BECOME DAMAGED THUS PREVENTING FULL SEATING OF EITHER FINAL ABUTMENT AND HEALING ABUTMENT, TOOTH 30.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18560418 ↗InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERI-IMPLANTITIS AROUND TOOTH 36 . IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18255911 ↗InjuryOct 20, 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 #13 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 17975521 ↗
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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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