OSSEOTITE® CERTAIN® IFNT411Recalls & reported problems
ZimVie US Corp LLC · FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 11.5MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Osseotite Certain dental implant is a root-form implant placed in the jaw to hold replacement teeth. Reports mostly describe infection around the implant with bone loss and pain, often ending with the implant loosening or being removed. There are 25 reports naming its identifier, with no deaths and 25 mentioning injury. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00844868005018), received between Oct 18, 2019 and Nov 19, 2025 — classified as 25 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 Problem24
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection19
- Osteolysis9
- Pain9
- Edema5
- No Code Available5
- Inadequate Osseointegration4
- Inflammation4
- Abscess2
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryNov 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 #12 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23598277 ↗InjuryAug 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 #11 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT LOST ITS INTEGRATION AND CAME OUT OF THE MOUTH. THERE WAS A LARGE INFECTION ALL AROUND THE IMPLANT SYMPTOMS AS A RESULT OF THE EVENT: PAIN & INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22708289 ↗InjuryMay 1, 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 #13 FAILED DURING IMPRESSION AND PERFORATED THE SINUS. BONE LOSS WAS ALSO REPORTED.
Patient problems: Osteolysis; Sinus Perforation
MAUDE report 21945835 ↗InjuryMar 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO ALLERGIC REACTION. SEVERE PAIN ALSO REPORTED. BONE GRAFT BY 2ND DDS. TOOTH #30. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Hypersensitivity/Allergic reaction; Pain
MAUDE report 21546190 ↗InjuryMar 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 LOCATION #14 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21513640 ↗InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING UN-COVERY, IT WAS NOTED THAT THE IMPLANT AT TOOTH LOCATION #27 HAD FAILED DUE TO BONE LOSS AND INFECTION. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 21283237 ↗InjuryOct 18, 2024Adverse 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: Osteolysis; Unspecified Infection
MAUDE report 20486760 ↗InjuryOct 18, 2024Adverse 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: Osteolysis; Pain; Unspecified Infection
MAUDE report 20486524 ↗InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BONE LOSS IS REPORTED. IMPLANT EXFOLIATED WHILE PATIENT AT HOME. TOOTH #28 (UNIVERSAL).
Patient problems: Osteolysis
MAUDE report 19549579 ↗InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH LOCATIONS #19 AND #20 WERE PLACED AND ONE (1) WEEK LATER AT FOLLOW UP, THE PATIENT WAS OK, BUT THEN STARTED FEELING PAIN. THE PATIENT ALSO HAD ERYTHEMA / FLUCTUANT AND THE IMPLANTS WERE REMOVED.
Patient problems: Erythema; Pain; Unspecified Infection
MAUDE report 16397730 ↗InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH LOCATIONS #19 AND #20 WERE PLACED AND ONE (1) WEEK LATER AT FOLLOW UP, THE PATIENT WAS OK, BUT THEN STARTED FEELING PAIN. THE PATIENT ALSO HAD ERYTHEMA / FLUCTUANT AND THE IMPLANTS WERE REMOVED.
Patient problems: Erythema; Pain; Unspecified Infection
MAUDE report 16397723 ↗InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #11 WAS REMOVED DUE TO A SINUS PERFORATION.
Patient problems: Sinus Perforation
MAUDE report 15763207 ↗InjuryJul 27, 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 INFECTION.
Patient problems: Abscess; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 15116796 ↗InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME BACK 3 DAYS AFTER IMPLANT PLACEMENT WITH A LOT OF PAIN, IMPLANT WAS REMOVED AND THE PAIN STOP. INFLAMMATION WAS ALSO REPORTED.
Patient problems: Inflammation; Pain
MAUDE report 12917244 ↗InjurySep 24, 2021Adverse 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: Osteolysis
MAUDE report 12526964 ↗InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection
MAUDE report 11942809 ↗InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT CLINICIAN INDICATED INFECTION, BONE LOSS. PATIENT RETURN WITH INFLAMMATION, PAIN, EDEMA, ABSCESS. TOOTH SITE # 8.
Patient problems: Abscess; Edema; Inflammation; No Code Available; Pain; Unspecified Infection
MAUDE report 11172843 ↗InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS THAT THE IFNT411 IMPLANT LOST INTEGRATION DUE TO PERI IMPLANTITIS AND WAS REMOVED.
Patient problems: Edema; Inflammation; Unspecified Infection
MAUDE report 10935713 ↗InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS THAT THE IFNT411 IMPLANT LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. INFLAMMATION AND EDEMA IS ALSO REPORTED.
Patient problems: Edema; Inadequate Osseointegration; Inflammation; No Code Available; Unspecified Infection
MAUDE report 10615982 ↗InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS THAT THE IFNT411 IMPLANT LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. EDEMA IS ALSO REPORTED. TOOTH SITE # 29.
Patient problems: Edema; Inadequate Osseointegration; No Code Available; Unspecified Infection
MAUDE report 10615224 ↗InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT THE IFNT411 IMPLANT LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. EDEMA IS ALSO REPORTED. TOOTH SITE # 28.
Patient problems: Edema; Inadequate Osseointegration; No Code Available; Unspecified Infection
MAUDE report 10615131 ↗InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITS.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9841252 ↗InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND DISCOMFORT. IMPLANT WAS REMOVED AND PATIENT WILL RETURN IN FUTURE FOR REPLACEMENT.
Patient problems: Discomfort; Unspecified Infection
MAUDE report 9648928 ↗InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT (IFNT411) WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 9384828 ↗InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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