OSSEOTITE® CERTAIN® XIFNT411Recalls & reported problems
ZimVie US Corp LLC · 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 has 139 adverse event reports, with no deaths and 134 injuries. Many describe infection and bone loss around the implant, with some reports saying the implant was removed, along with pain and swelling. 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
- 140
- Deaths reported
- 0
- Injuries reported
- 135
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 00844868021964), received between May 1, 2019 and Aug 3, 2026 — classified as 135 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (14 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 Problem117
- Fracture14
- Mechanical Problem5
- Device Markings/Labelling Problem2
- Loss of Osseointegration1
- Patient-Device Incompatibility1
- Unsealed Device Packaging1
Patient problems
- Unspecified Infection76
- Osteolysis69
- Pain30
- Inflammation22
- No Information21
- No Clinical Signs, Symptoms or Conditions17
- No Code Available6
- Abscess4
Recent adverse event reports
The 25 most recent of 140 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported patient developed subperiosteal abscess leading to graft resorption. Implant at tooth site 8 was removed due to infection.
Patient problems: Abscess; Unspecified Infection
MAUDE report 50113936 ↗InjuryJul 29, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
It was reported implant was removed due to periimplantitis and loss of integration, discovered during clinical procedure. Tooth site 13.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50066519 ↗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: Osteolysis; Unspecified Infection
MAUDE report 24871217 ↗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 24871168 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 24716675 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 24715946 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A LOSS OF INTEGRATION AT TOOTH SITE #36 DUE TO A PERI-IMPLANTITIS. PATIENT HAD ABSCESS, PAIN AND AN EDEMA. IMPLANT WAS REMOVED.
Patient problems: Abscess; Osteolysis; Swelling/ Edema
MAUDE report 24713176 ↗InjuryMar 24, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24679463 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24456642 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT PRESENTED FOR INTEGRATION CHECK OF IMPLANT #7. PATIENT COMPLAINED OF SEVERE PAIN WITH TORQUE. PATIENT ELECTED TO REMOVE THE IMPLANT AND BONE GRAFT THE SITE FOR FUTURE IMPLANT. THE IMPLANT WAS REMOVED AND THE SITE WAS BONE GRAFTED. THE PATIENT WILL REPLACE IN 4 MONTHS WITH NEW IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain
MAUDE report 24193276 ↗InjuryDec 20, 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 INFECTION. PATIENT WILL RETURN TO COMPLETE THE PROCEDURE. SYMPTOMS AS A RESULT OF THE EVENT: SUPPURATION AND PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 23858754 ↗InjuryDec 5, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727315 ↗InjuryNov 26, 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 AN INFECTION AROUND THE IMPLANT.
Patient problems: Unspecified Infection
MAUDE report 23656843 ↗InjuryNov 10, 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 #9 WAS REMOVED DUE TO INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23513138 ↗InjuryOct 29, 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. TOOTH SITE #43.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23415093 ↗InjuryOct 27, 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 PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23396472 ↗InjuryOct 24, 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. TOOTH # 5.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23380060 ↗InjuryOct 15, 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 #6 WAS REMOVED DUE TO THE LOSS OF INTEGRATION AND BONE LOSS ASSOCIATED WITH PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23303790 ↗InjuryAug 19, 2025Adverse 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: Bone Fracture(s); Osteolysis
MAUDE report 22843234 ↗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 22379991 ↗InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT AN UNKNOWN TOOTH SITE WAS REMOVED DUE TO A PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22335293 ↗InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REGULAR FULL FLAP APPROACH WAS PERFORMED TO PLACE THE IMPLANT AT THE FIRST MOLAR (UPPER RIGHT) SITE, #16 WITH 8MM OF BONE UNDER THE SINUS FLOOR. THE IMPLANT WAS PLACED RIGHT AFTER A BONE GRAFT (INTERNAL SINUS LIFT) WAS DONE; BUT IT WAS A BIT TOO LONG (INTO THE SINUS) AND PERFORATED THE SINUS, SO IT WAS REMOVED AND A 10MM IMPLANT WAS PLACED INSTEAD.
Patient problems: Sinus Perforation
MAUDE report 22235196 ↗InjuryJun 9, 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 46 TOOK A BAD POSITION GOING THROUGH THE LINGUAL PLATE AND THE DENTURE BRIDGE. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANT AND PATIENT WILL RETURN TO PLACE A NEW IMPLANT. PAIN, INFLAMMATION AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Pain
MAUDE report 22165649 ↗InjuryMay 29, 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 #5 WAS FOUND IN THE PATIENT'S SINUS. THIS WAS CONFIRMED WHEN THE PATIENT ATTENDED THE SECOND STAGE OF THE PROCEDURE. THE IMPLANT WAS REMOVED AND THE SITE WAS GRAFTED.
Patient problems: Sinus Perforation
MAUDE report 22108031 ↗MalfunctionApr 3, 2025Unsealed Device Packaging; Unsealed Device Packaging
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21760362 ↗
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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 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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