OSSEOTITE® OSS411Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® IMPLANT 4 X 11.5MM · Class 2 · Implant
All models of OSSEOTITE (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a ZimVie OSSEOTITE endosseous dental implant, used as a root-form anchor in the jaw. The 55 reports mostly describe implants breaking or snapping, sometimes at the collar, along with bone loss around the implant, infection, and pain that led to the implant being removed and replaced. There were 54 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
- 55
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00844868013181), received between Feb 5, 2020 and Jul 8, 2025 — classified as 54 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (27 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 Problem27
- Fracture27
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Osteolysis17
- Unspecified Infection15
- No Information11
- Pain6
- Discomfort2
- No Code Available2
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22434597 ↗InjuryJul 8, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22434524 ↗InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Nerve Damage; Paresthesia
MAUDE report 22200403 ↗InjuryMay 5, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Osteolysis
MAUDE report 21959715 ↗InjuryMay 5, 2025Fracture; Fracture
THE PATIENT WENT TO THE DENTIST OFFICE DUE TO DISCOMFORT AND MOBILITY FROM IMPLANTS AT TOOTH SITE #35-36. DURING THE CHECKUP, IT WAS DETECTED THAT THERE WAS SLIGHT BONE LOSS AND BOTH IMPLANTS WERE FRACTURED AT THE BOTTOM AND THE COLLAR. IMPLANTS WERE COMPLETELY REMOVED.
Patient problems: Discomfort; Osteolysis
MAUDE report 21959665 ↗InjuryNov 19, 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 PERI-IMPLANTITIS AT TOOTH LOCATION 37.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20722685 ↗InjuryOct 25, 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 #36 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20531014 ↗InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 19790556 ↗InjuryJul 8, 2024Adverse 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 22 & 24 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19687747 ↗InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 14 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19095404 ↗InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED BONE LOSS AT TOOTH SITES 31, 34, 27. IMPLANTS WERE REMOVED.
Patient problems: Osteolysis
MAUDE report 18998769 ↗InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 18984129 ↗InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED BONE LOSS AT TOOTH SITES 32, 33. IMPLANTS WERE REMOVED.
Patient problems: Osteolysis
MAUDE report 18984119 ↗MalfunctionFeb 28, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18798336 ↗InjuryJan 4, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 13 AND 14 FRACTURED AND WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18443731 ↗InjuryJan 4, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 13 AND 14 FRACTURED AND WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18443606 ↗InjuryJun 14, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 17123327 ↗InjuryJun 1, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17040397 ↗InjuryMay 24, 2023Fracture; Fracture
IT WAS REPORTED THAT THE CROWN WAS MOBILE, AND THE DOCTOR DISCOVERED THAT THE IMPLANT BODY WAS FRACTURED AND REMOVED IT. NO OTHER IMPLANT HAS BEEN PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16991675 ↗InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTED THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #19 FAILED DUE TO PERI-IMPLANTITIS. THE SYMPTOMS AS A RESULT OF THE EVENT IS PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 16725576 ↗InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTED THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #6 FAILED DUE TO PERI-IMPLANTITIS. THE SYMPTOMS AS A RESULT OF THE EVENT IS PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 16725558 ↗InjuryFeb 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 16453041 ↗InjuryFeb 20, 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 POSITION #31 FAILED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16403537 ↗InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #25 WAS REMOVED DUE TO MEMBRANE RUPTURE. SIMULTANEOUS SINUS LIFT. MEMBRANE RUPTURED AND COULDN'T BE REPAIRED, SO PROCEDURE WAS ABORTED, AND HE IMPLANT ALREADY PLACED WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16323434 ↗InjuryOct 14, 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 PERI-IMPLANTITIS WITH PAIN AND INFLAMMATION AT THE SITE.
Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection
MAUDE report 15608342 ↗
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- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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 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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