OSSEOTITE® CERTAIN® INT510Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 10MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN (74)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a ZimVie Osseotite Certain INT510 dental implant, a small screw-shaped implant used as a tooth root replacement. The 36 reports mostly describe implants that failed after placement, with bone loss around the implant (peri-implantitis), infection, pain, or bone fracture, and many implants had to be removed;35 reports involve injuries and no deaths. There have been no recalls naming 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
- 35
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00844868006695), received between Oct 18, 2019 and May 20, 2026 — classified as 34 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).
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 Problem33
- Loss of Osseointegration1
- Patient-Device Incompatibility1
- Problem with Removal of Enzymatic Cleaner1
- Unsealed Device Packaging1
Patient problems
- Osteolysis19
- Unspecified Infection18
- No Information5
- No Clinical Signs, Symptoms or Conditions4
- Bone Fracture(s)3
- Pain3
- Inflammation2
- Discomfort1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS REMOVED DUE TO BONE LOSS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis
MAUDE report 25231595 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 12 WAS REMOVED DUE TO PERI-IMPLANTITIS. RESTORATION WITH AN UPPER OVERDENTURE IS PERFORMED, PATIENT CAME TO CLINICIAN REFERRING DISCOMFORT AND DOCTOR NOTICED INFECTION ON IMPLANT'S SIDE.
Patient problems: Discomfort; Osteolysis; Unspecified Infection
MAUDE report 25147028 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER 24 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.THE DOCTOR REPORTED: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24888173 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 16 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24372513 ↗InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24118738 ↗InjuryNov 5, 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 #30 WAS REMOVED DUE TO BONE LOSS. DISCOVERED DURING OSSEOUS TO ATTEMPT TO SAVE THE IMPLANT. THE IMPLANT WAS REPLACED.
Patient problems: Osteolysis
MAUDE report 23479992 ↗InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING IMPLANT PLACEMENT, THE BUCCAL PLATE FRACTURED AND THE CLINICIAN COULDN'T GET ADEQUATE STABILIZATION. THE PROCEDURE WAS UNABLE TO COMPLETE THE PROCEDURE.
Patient problems: Bone Fracture(s)
MAUDE report 22546520 ↗InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #46 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20299951 ↗InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #17 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: UNKNOWN.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19642272 ↗InjuryJun 4, 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 CAME IN WITH PAIN.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19462142 ↗InjuryMay 21, 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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19362189 ↗InjuryJan 31, 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 18612881 ↗InjuryDec 29, 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 #18. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18417166 ↗MalfunctionSep 20, 2023Unsealed Device Packaging; Unsealed Device Packaging
THE DOCTOR REPORTS THAT THE PACKAGING OF THE BOX WAS NOT SEALED ON THE INSIDE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT'S HEALTH AND THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT FROM THE DOCTOR'S STOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17778583 ↗InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH LOCATION # 21 AND 23 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOM AS A RESULT OF EVENT: INFLAMMATION AND PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 17559947 ↗InjuryJun 9, 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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17098647 ↗InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 16 AND 17 WERE REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION, PAIN AND DISCOMFORT WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Pain; Purulent Discharge; Unspecified Infection
MAUDE report 17010905 ↗InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Bone Fracture(s); Inflammation
MAUDE report 16497987 ↗InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN THE BUCCAL POSITIONS NUMBERS 24 FAILED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16305501 ↗InjuryJan 24, 2023Problem with Removal of Enzymatic Cleaner; Adverse Event Without Identified Device or Use Problem; Problem with Removal of Enzymatic Cleaner; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16232492 ↗InjuryJul 22, 2022Adverse 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. SYMPTOMS AS A RESULT OF THE EVENT: SENSITIVITY.
Patient problems: Hyperresponsive to stimuli; Osteolysis; Unspecified Infection
MAUDE report 15084294 ↗InjuryJul 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO ALLERGIC REACTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN, PRESSURE AND SWELLING.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 15083654 ↗InjuryFeb 1, 2022Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 13419303 ↗InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 8 LACKED PRIMARY STABILITY, AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12922640 ↗InjuryOct 7, 2021Adverse 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: Osteolysis; Unspecified Infection
MAUDE report 12588908 ↗
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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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