OSSEOTITE® CERTAIN® PREVAIL XIITP5485Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 5/4 X 8.5MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN PREVAIL (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a ZimVie OSSEOTITE Certain Prevail dental implant, a screw-shaped root-form device placed in the jaw to support a tooth. Most of the 62 reports describe implants that later became loose or were removed because of bone loss, infection around the implant (peri-implantitis), fistula, or pain, and one mentions a damaged internal connection and one a fracture. There are 59 injuries and no deaths. No recalls name this device, and reports have dropped from 12 in the prior 12 months to 5 in the most recent.
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
- 61
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00844868022190), received between Jul 29, 2019 and Apr 20, 2026 — classified as 58 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (6 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 Problem53
- Mechanical Problem6
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection31
- Osteolysis26
- Pain14
- No Code Available11
- No Clinical Signs, Symptoms or Conditions10
- Inflammation6
- Sinus Perforation4
- Abscess3
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS MOBILE AND FAILED DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24926257 ↗InjuryFeb 18, 2026Adverse 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 24381883 ↗MalfunctionFeb 18, 2026Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378503 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONSTANT PAIN AT TOOTH SITE #28. A DEBRIDEMENT PROCEDURE WAS PERFORMED AND THE IMPLANT WAS REMOVED. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 23692944 ↗InjuryOct 16, 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 BONE LOSS. FISTULA PRESENT. PER INDICATED: ADDITIONAL APPOINTMENT REQUIRED: YES, REPLACE IMPLANT #4.
Patient problems: Fistula; Osteolysis
MAUDE report 23312896 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23305232 ↗MalfunctionSep 18, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THE INTERNAL CONNECTION WAS DAMAGED. PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT. NO IMPACT ON THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23082881 ↗InjurySep 11, 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: Pain
MAUDE report 23025747 ↗InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD RESTORATION DONE AND CAME WITH MOBILITY ON THE CROWN. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22492976 ↗InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22293754 ↗InjuryJun 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 #3 WAS REMOVED DUE TO PAIN UNDER PROSTHESIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 22284879 ↗InjuryJun 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 #18 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22283712 ↗MalfunctionJun 2, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED IMPORT STRIPPED DURING PLACEMENT, NOTICED INTERNALLY, TOOTH 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22129291 ↗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 #15 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22082049 ↗InjuryApr 21, 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 BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & BLEEDING ON PROBING.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Osteolysis
MAUDE report 21874755 ↗InjuryJan 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 #18 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21283238 ↗InjuryOct 28, 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: Sinus Perforation
MAUDE report 20548434 ↗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 # 18. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 20034327 ↗InjuryApr 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 #19 NOTED ON RADIOGRAPH. THEREFORE, THE IMPLANT WAS REMOVED. GRANULATION TISSUE REMOVED AND SITE IRRIGATED, PLACED PUROS AND COLLAPLUG FOR FUTURE IMPLANT REPLACEMENT.
Patient problems: Osteolysis
MAUDE report 19103437 ↗InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERI-IMPLANTITIS TOOTH # 3.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18959207 ↗InjuryNov 30, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18236192 ↗InjurySep 19, 2023Adverse 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 #14. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17773052 ↗InjurySep 11, 2023Adverse 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 #14. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17726747 ↗InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED PERI-IMPLANTITIS, TOOTH 14. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17625766 ↗InjuryAug 17, 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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17563474 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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