OSSEOTITE® CERTAIN® XIFNT485Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 8.5MM · Class 2 · Implant
Quick summary
This OsseoTite Certain XIFNT485 is a small endosseous dental implant used as a tooth root replacement. The 73 reports mostly describe implants that had to be taken out after failing to heal in place, mainly because of peri-implantitis and bone loss around the implant, with patients reporting pain, swelling and infection. The reports describe 71 injuries and no deaths. 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
- 73
- Deaths reported
- 0
- Injuries reported
- 71
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00844868021995), received between Oct 3, 2019 and May 4, 2026 — classified as 71 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (3 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. 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 Problem66
- Mechanical Problem3
- Fracture2
- Component Missing1
- Failure to Osseointegrate1
- Loss of Osseointegration1
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection47
- Osteolysis36
- Inflammation13
- Pain13
- No Information8
- No Code Available7
- No Clinical Signs, Symptoms or Conditions5
- Swelling/ Edema5
Recent adverse event reports
The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.
InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT(S) AT TOOTH SITE # 14+36 WERE REMOVED DUE TO A PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25065705 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 14,15,17 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24870576 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER 47 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24726896 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, EDEMA AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24521983 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #37 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24084997 ↗InjuryDec 4, 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 #24 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23717683 ↗InjuryDec 3, 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 CORONAL BONE LOSS. AN ADDITIONAL APPOINTMENT WAS ANTICIPATED TO REPLACE THE IMPLANT.
Patient problems: Osteolysis
MAUDE report 23708377 ↗InjuryNov 6, 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: Inflammation; Osteolysis; Pain
MAUDE report 23489957 ↗InjuryNov 6, 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: Inflammation; Osteolysis; Pain
MAUDE report 23489833 ↗InjuryAug 19, 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 #20 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22837661 ↗InjuryJul 21, 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 #18 AND #19 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: SWELLING, INFLAMMATION AND PAIN.
Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection
MAUDE report 22558264 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED PAIN MEDICATION (DILAUDID 1 MG) AS PATIENT HAD SIGNIFICANT PAIN. THIS WAS PRESCRIBED BEFORE THE IMPLANT REMOVAL. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 22333498 ↗InjuryJun 23, 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 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS REPORTED ON THE PATIENT: PAIN, INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22306214 ↗InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A LOSING OF INTEGRATION DUE TO PERIIMPLANTITIS AT TOOTH SITES 34 - 35. BOTH IMPLANTS WERE REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22156978 ↗InjurySep 4, 2024Adverse 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 BONE LOSS. TOOTH NUMBER 19.
Patient problems: Osteolysis
MAUDE report 20138418 ↗InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AN INFECTION AT TOOTH SITE #25. IMPLANT WAS REMOVED. BONE TYPE: II. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION + IMPLANT MOBILITY + INFECTION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 19826970 ↗InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED INFECTION WITH INFLAMMATION AT TOOTH SITE 36. PATIENT REFERRED PAIN.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 19793953 ↗InjuryJul 22, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Osteolysis; Unspecified Infection
MAUDE report 19790713 ↗InjuryMay 29, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT CONNECTION WAS DAMAGED DURING IMPLANT PLACEMENT AT 55 N AND IS DEFORMED. IMPLANT HAD TO BE REMOVED USING FORCEPS. DOCTOR DID NOT FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19412871 ↗InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #30 HAD SIGNIFICANT BONE LOSS AROUND IMPLANT, THEREFORE IT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 19391877 ↗InjuryApr 15, 2024Fracture; Fracture
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER 36 FAILED BECAUSE IT FRACTURED BY THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: II. THE DOCTOR REPORTED : BRUXISM.
Patient problems: Bruxism
MAUDE report 19107071 ↗InjuryApr 15, 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: III. THE DOCTOR REPORTED : SMOKER.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19106080 ↗InjuryMar 8, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865583 ↗InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT COMPLAINED OF PAIN AND SWELLING, IMPLANT REMOVED, TOOTH 19. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 18588534 ↗InjuryNov 15, 2023Adverse 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 IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18144634 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.