OSSEOTITE® CERTAIN® XIFNT413Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 13MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN (74)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Osseotite Certain XIFNT413 is a 4 x 13 mm endosseous (root-form) dental implant used to replace missing teeth. The 59 adverse event reports mostly describe implants being taken back out of the mouth because of peri-implantitis, an infection and inflammation around the implant that led to pain, bone loss (osteolysis), and in a few cases a fractured implant. There are 56 injuries and no deaths. No recalls name this device, and report counts have changed only slightly between the last two 12-month periods (7 versus 9).
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
- 59
- Deaths reported
- 0
- Injuries reported
- 56
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00844868021971), received between Feb 7, 2020 and May 19, 2026 — classified as 56 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (4 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 Problem54
- Mechanical Problem4
- Fracture1
Patient problems
- Unspecified Infection43
- Osteolysis36
- Inflammation13
- Pain12
- No Clinical Signs, Symptoms or Conditions5
- No Information4
- Abscess3
- Swelling/ Edema3
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #46, #32, #42 AND UNKNOWN LOCATION WERE REMOVED DUE TO ACUTE PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25218886 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #46, #32, #42 AND UNKNOWN LOCATION WERE REMOVED DUE TO ACUTE PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25218747 ↗InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #25 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 25110328 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 32 WAS REMOVED DUE TO ACUTE PERI-IMPLANTITIS. DOCTOR PERFORMED GBR WITH BONE AND MEMBRANE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24637647 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE 46 WAS REMOVED DUE TO PERI-IMPLANTITIS.PATIENT BONE TYPE III.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24604297 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #16 AND #46 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24535351 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24524690 ↗InjuryOct 27, 2025Adverse 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 23397005 ↗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 #11 WAS REMOVED DUE TO BONE LOSS & BONE FRACTURE. STANDARD OSTEOTOMY WAS PERFORMED & IMPLANT 4 X 13 WAS PLACED WITH GOOD PRIMARY STABILITY. HEALING ABUTMENT WAS ALSO PLACED. THEN I NOTICED SOME GRANULATION AFTER TISSUE REMAINING ON APICAL BONE BUCCAL PLATE & I REALIZED THAT THE BONY DEFECT WAS NOT COMPLETELY FILLED WITH BONE IN APICAL PORTION OF IMPLANT. THE 3 APICAL IMPLANT SCREW THREADS WERE EXPOSED. APICAL BUCCAL PLATE PERFORATION OCCURRED DURING THE PROCEDURE.
Patient problems: Bone Fracture(s); Osteolysis
MAUDE report 22843236 ↗InjuryAug 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN POSITIONS #26 & #22 FAILED DUE TO SEVERE PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22823796 ↗InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN AN UNKNOWN DENTAL POSITION FAILED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22467264 ↗InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITES 14, 32, 42 AND 15. IMPLANTS WERE REMOVED AND THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22379964 ↗InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITES 14, 32, 42 AND 15. IMPLANTS WERE REMOVED AND THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22379899 ↗InjuryJun 24, 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 #23 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS REPORTED ON THE PATIENT: PAIN, INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22323557 ↗InjuryMay 14, 2025Adverse 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 #12 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. FISTULA WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Fistula; Osteolysis; Unspecified Infection
MAUDE report 22017876 ↗InjuryFeb 5, 2025Adverse 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 21310875 ↗InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED PERI IMPLANTITIS AND WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20521547 ↗InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT PRESENTED WITH IMPLANT #11 WITH PERI IMPLANTITIS, LOSS OF INTEGRATION. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20320045 ↗InjuryJul 9, 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: Pain
MAUDE report 19704943 ↗InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT WENT TO THE DENTIST OFFICE SUFFERING PAIN AT THE IMPLANT AT TOOTH SITE #22 . IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN + EDEMA + INFLAMMATION.
Patient problems: Inflammation; Pain; Swelling/ Edema
MAUDE report 19183194 ↗InjuryFeb 27, 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 # 27 HAD INFECTION AND WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 18792756 ↗MalfunctionFeb 23, 2024Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18766477 ↗InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED REMOVED IMPLANT DUE TO BONE LOSS, CLEANED OUT SOCKET TO HEAL, TOOTH SITE 8.
Patient problems: Osteolysis
MAUDE report 18732144 ↗InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED PATIENT CAME IN WITH PAIN AND SWELLING. IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH 9(UNIVERSAL). SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Unspecified Infection
MAUDE report 18565631 ↗InjuryNov 29, 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 18228932 ↗
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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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