OSSEOTITE® CERTAIN® PREVAIL XIITP6511Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 6/5 X 11.5 MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN PREVAIL (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a ZimVie OSSEOTITE dental implant, a small screw-shaped device placed in the jaw to hold a tooth replacement. The 50 reports mostly describe implants that became loose or were removed after infection around the implant, with bone loss and pain;45 reports involved injuries and no deaths were reported. A few reports mention mechanical problems with the implant itself. The number of reports held steady at 6 over each of the past two 12-month periods, 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
- 50
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00844868022213), received between Dec 2, 2019 and Apr 1, 2026 — classified as 45 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (7 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem43
- Mechanical Problem7
Patient problems
- Unspecified Infection22
- Osteolysis14
- No Clinical Signs, Symptoms or Conditions12
- Pain12
- Abscess3
- No Code Available3
- No Information3
- Swelling/ Edema2
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY MAIL THAT THE IMPLANT IN SITE 3 WAS MOBILE AND FAILED DUE TO PERI-IMPLANTITIS. PATIENT WILL RETURN FOR NEW IMPLANT AND BONE GRAFT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24758383 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS MOBILE. THE IMPLANT HAD FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24605033 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS MOBILE AND FAILED DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24470617 ↗InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS BONE LOSS WITH TISSUE RECESSION AROUND THE IMPLANT. THE IMPLANT WAS REMOVED. TOOTH LOCATION IS UNKNOWN.
Patient problems: Osteolysis
MAUDE report 23922158 ↗MalfunctionDec 9, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT PATIENT HAD CROWN PLACED AND WAS MOBILE, CROWN REMOVED AND IMPLANT STABLE BUT PAIN. CROWN REPLACED BUT STILL MOBILE IMPLANT REMOVED AND REPLACED. TOOTH SITE: 30. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 23757866 ↗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 THE IMPLANT AT TOOTH SITE #19 AND CONTINUED TO HAVE PAIN AND A COLD SENSATION IN THEIR LOWER JAW. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 23692786 ↗InjuryOct 16, 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
MAUDE report 23311228 ↗InjurySep 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 #14 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 23071742 ↗InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT NEEDED TO BE PLACED DEEPER TO ALLOW SPACE FOR IMPLANT CROWN, PROPER OCCLUSION. TOOTH NUMBER 31. IMPLANT REPLACED WITH A DIFFERENT IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21909119 ↗InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #30 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 21377181 ↗InjuryDec 14, 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 #19 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 20932600 ↗InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. GRANULATION TISSUE AROUND IMPLANT CAUSING PAIN AND NON HEALING. 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: NO. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO.
Patient problems: Unspecified Infection
MAUDE report 20650969 ↗InjurySep 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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20257106 ↗InjuryAug 12, 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: Unspecified Infection
MAUDE report 19959246 ↗InjuryJul 9, 2024Adverse 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 19700825 ↗InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19160028 ↗InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DOCTOR TRIED TO PLACE THE IMPLANT AT TOOTH LOCATION #18, HOWEVER A POSSIBLE BUCCAL FRACTURE WAS NOTED BECAUSE THE TORQUE WAS GOOD THEN IT WASN'T. THE IMPLANT WAS UNABLE TO BE PLACED AND THE SOCKET WAS GRAFTED. THE PATIENT WILL RETURN TO THE CLINIC IN FOUR (4) MONTHS TO PLACE A NEW IMPLANT.
Patient problems: Bone Fracture(s)
MAUDE report 19143179 ↗InjuryMar 7, 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 #19 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18857074 ↗InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERI-IMPLANTITIS, TOOTH14. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18375512 ↗MalfunctionDec 4, 2023Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18256712 ↗InjuryAug 29, 2023Adverse 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 LOST INTEGRATION DUE TO PERIIMPLANTITIS AND WAS REMOVED AND BONE GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17646946 ↗MalfunctionAug 28, 2023Mechanical Problem; Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17631624 ↗InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TOOTH SITE # 19 WAS INFECTED AND THE PATIENT HAD PAIN. THE IMPLANT WAS REMOVED, AND BONE GRAFT PLACED.
Patient problems: Pain; Unspecified Infection
MAUDE report 17080683 ↗InjuryMay 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED REMOVAL OF IMPLANT DUE TO IMPLANT POSITIONING. UNABLE TO RESTORE WITH IMPLANT CROWN. REMOVED AND REPLACEMENT. TOOTH 18 (UNIVERSAL).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16883746 ↗InjuryMay 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED PERI-IMPLANTITIS AND LOSS OF INTEGRATION AROUND THE IMPLANT AT TOOTH LOCATION #30. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 16883032 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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