OSSEOTITE® CERTAIN® INT485Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 8.5MM · Class 2 · Implant
Quick summary
This Osseotite Certain INT485 dental implant is a root-form endosseous implant used to anchor replacement teeth. The 39 reports describe implants failing to fuse or becoming infected, with surrounding bone loss (osteolysis), pain, and inflammation, sometimes requiring removal. There were 39 injuries and no deaths, and no recalls name this device. Reports rose from 4 in the previous 12 months to 14 in the most recent 12 months.
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
- 34
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00844868006688), received between Aug 19, 2020 and May 27, 2026 — classified as 34 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem34
- Failure to Osseointegrate1
Patient problems
- Osteolysis25
- Unspecified Infection22
- Pain12
- Inflammation7
- Discomfort2
- No Clinical Signs, Symptoms or Conditions2
- Sinus Perforation2
- Abscess1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO INFECTION AND BONE LOSS. PATIENT PREVIOUSLY RECEIVED REHABILITATION WITH AN OVERDENTURE. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT.
Patient problems: Discomfort; Osteolysis; Unspecified Infection
MAUDE report 25306267 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #44 AND #46 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 25184950 ↗InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24099165 ↗InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S BODY REJECTED THE IMPLANT AT TOOTH SITE #3. THE PATIENT EXPERIENCED PAIN AND DISCOMFORT AND THE IMPLANT WAS REMOVED DUE TO BONE LOSS.
Patient problems: Discomfort; Osteolysis; Pain
MAUDE report 24098509 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 24081688 ↗InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 23831280 ↗InjuryDec 12, 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 #47 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23791429 ↗InjuryDec 8, 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 #16 LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT. DR. REPORTS THEY WILL PERFORM A SINUS ELEVATION WITH BIO-OSS XENOGRAFT. PATIENT BONE TYPE IS INDICATED AS II-III.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23736492 ↗InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED FROM TOOTH SITES #24, #25, AND #26 DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23729325 ↗InjuryJun 14, 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 #47 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REPORTED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22208359 ↗InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 16 AND 26 WERE REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 21891017 ↗InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS ON TOOTH LOCATION 44 ,45 AND 46 WERE REMOVED DUE TO PAIN. PATIENT EXPERIENCED SUCH A PAIN THAT ARRIVED UNTIL THE EYE. DOCTOR DISCARDED PERI IMPLANTITIS AND GUMS ARE OK AS WELL.
Patient problems: Pain
MAUDE report 21759949 ↗InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A BONE LOSS. IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 20705877 ↗InjuryAug 20, 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 #35 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: UNKNOWN.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20008983 ↗InjuryJul 24, 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 16 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: UNKNOWN. THE DOCTOR REPORTED : SMOKER + POOR ORAL HIGYENE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19817117 ↗InjuryJun 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 #22 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19492658 ↗InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A BONE LOSS AND A INFECTION AT TOOTH SITE #25-27. PATIENT SUFFERED PAIN AND INFLAMMATION. BOTH IMPLANTS WERE REMOVED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19445350 ↗InjuryNov 27, 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 11 AND 15 WERE REMOVED DUE TO PERI-IMPLANTITS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18212402 ↗InjuryJul 13, 2023Adverse 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 17315672 ↗InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH #12/22 WERE REMOVED DUE TO PERI-IMPLANTITIS. ABSCESS WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17215377 ↗InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT AT TOOTH #15 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED THE SYMPTOM OF THIS EVENT IS INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 16885116 ↗InjuryFeb 13, 2023Adverse 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.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16361732 ↗InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS "INFLAMMATION".
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 16265152 ↗InjuryNov 15, 2022Adverse 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. THIS WAS NOTICED AT FOLLOW UP.
Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection
MAUDE report 15797949 ↗InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION 36 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 15595803 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.