OSSEOTITE® OSS311Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® IMPLANT 3.75 X 11.5MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is a ZimVie Osseotite endosseous dental implant, a small screw-shaped device placed in the jaw to replace a tooth. The 51 reports mostly describe the implant breaking or snapping, sometimes years after it was placed, which often meant removing it and leaving the procedure unfinished; a few also mention infection, pain, and bone loss around the site. There are no deaths and 47 injuries. 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
- 52
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00844868013112), received between Oct 18, 2019 and Sep 18, 2026 — classified as 48 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (44 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
- Fracture44
- Adverse Event Without Identified Device or Use Problem7
- Loss of Osseointegration1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Information13
- Pain6
- Unspecified Infection6
- Osteolysis5
- Failure of Implant3
- Discomfort2
- No Code Available2
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Fracture
The doctor reports that the dental implant failed because it fractured at the body. Tooth site 35.The doctor reports that the procedure was concluded by placing another implant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816977 ↗InjurySep 18, 2026Fracture
The doctor reports that the dental implant failed because it fractured at the body. Tooth site 35.The doctor reports that the procedure was not concluded by placing another implant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816913 ↗InjuryMay 29, 2026Fracture
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER 36 FAILED BECAUSE IT FRACTURED AT THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25328286 ↗InjuryMay 21, 2026Fracture; Loss of Osseointegration
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER 16 FAILED BECAUSE IT FRACTURED AT THE HEAD. LOSS OF INTEGRATION WAS ALSO REPORTED. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25240507 ↗InjuryFeb 19, 2026Fracture
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 46 WAS REMOVED DUE TO THE IMPLANT FRACTURE AT THE BODY, THAT LEAD TO IMPLANT MOBILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388613 ↗InjuryFeb 19, 2026Fracture
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 26 WAS REMOVED DUE TO THE IMPLANT FRACTURE AT THE BODY. PATIENT WILL RETURN TO PLACE A NEW IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388375 ↗InjuryJan 9, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 24018522 ↗InjuryDec 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 # 22 WAS REMOVED DUE TO AN INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND DISCOMFORT.
Patient problems: Discomfort; Pain; Unspecified Infection
MAUDE report 23853485 ↗InjuryNov 20, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23604235 ↗InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A LOSS OF INTEGRATION DUE TO A PERI-IMPLANTITIS AROUND TOOTH SITE #36 AND THE IMPLANT WAS REMOVED. PAIN WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22838623 ↗InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #14 & #15 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 22191898 ↗MalfunctionMar 7, 2025Unsealed Device Packaging; Unsealed Device Packaging
THE DOCTOR REPORTS THAT THE IMPLANT¿S PACKAGING WAS OPEN, WITH THE MOUNTING DEVICE DETACHED FROM THE IMPLANT. DOCTOR CONFIRMED THAT THE EVENT WAS DISCOVERED AT THE EXACT MOMENT OF UNPACKING THE PRODUCT. NO IMPACT ON THE PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21552933 ↗InjuryDec 11, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 20902698 ↗InjuryDec 11, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20902684 ↗InjuryAug 8, 2024Fracture; Fracture
IT WAS REPORTED THAT THE OSS311 IMPLANT FRACTURED. THE TIP WAS REMOVED BUT COULD NOT BE RECOVERED. IF POSSIBLE, PLEASE INVESTIGATE AND CONFIRM THE RECOVERED PART. IT WILL BE RE-BURIED AT A LATER DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19939958 ↗InjuryJul 29, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 19850265 ↗InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 35, 37 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19612042 ↗InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 35, 37 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19611895 ↗InjuryJun 6, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 46 FRACTURED AT THE BODY OF THE IMPLANT AND WAS REMOVED. PROCEDURE WAS COMPLETED WITH OTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19481164 ↗InjuryFeb 22, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 36 FRACTURED AT THE BODY OF THE IMPLANT AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18758005 ↗InjuryNov 30, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18236137 ↗MalfunctionSep 5, 2023Fracture; Fracture
DOCTOR REPORTED THE IMPLANT FRACTURED AT TOOTH LOCATION #46, BOTTOM PART OF THE IMPLANT REMAINS IN PATIENT´S MOUTH. IT WAS PUT TO SLEEP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17687029 ↗InjurySep 5, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17685300 ↗InjuryJul 28, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17415368 ↗InjurySep 9, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BECOMING FRACTURED AT THE SITE.
Patient problems: Insufficient Information
MAUDE report 15396314 ↗
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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 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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