OSSEOTITE® OSS413Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® IMPLANT 4 X 13MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Osseotite dental implant is a root-form implant placed in the jaw to support teeth. Reports mostly describe bone loss around the implant, sometimes with the implant fracturing, with several mentioning removal. There are 25 reports naming its identifier, with no deaths and 23 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
- 25
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00844868013198), received between Mar 25, 2020 and May 13, 2024 — classified as 23 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (10 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 Problem15
- Fracture10
Patient problems
- Osteolysis12
- No Information8
- No Clinical Signs, Symptoms or Conditions4
- Inflammation3
- Unspecified Infection3
- Implant Pain2
- Bone Fracture(s)1
- No Code Available1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19297480 ↗InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 22, 21, 34. IMPLANTS WERE REMOVED.
Patient problems: Osteolysis
MAUDE report 18993038 ↗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 22, 21, 34. IMPLANTS WERE REMOVED.
Patient problems: Osteolysis
MAUDE report 18993016 ↗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 18992230 ↗InjuryMar 26, 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 43 45 AND 47 FAILED DUE TO BONE LOSS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. PATIENT WITH BONE TYPE: II.
Patient problems: Osteolysis
MAUDE report 18984076 ↗InjuryMar 26, 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 43 45 AND 47 FAILED DUE TO BONE LOSS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. PATIENT WITH BONE TYPE: II.
Patient problems: Osteolysis
MAUDE report 18984071 ↗InjuryMar 26, 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 43 45 AND 47 FAILED DUE TO BONE LOSS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. PATIENT WITH BONE TYPE: II.
Patient problems: Osteolysis
MAUDE report 18984068 ↗InjuryOct 14, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO THE BOTTOM HALF BECOMING FRACTURED WITH PERI-IMPLANTITIS WITH PAIN AND INFLAMMATION AT THE SITE.
Patient problems: Inflammation; No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 15608482 ↗InjuryMay 7, 2022Fracture; Fracture
IT WAS REPORTED THAT DR. INDICATED FRACTURE IMPLANT. THE PATIENT CAME TO THE CLINIC BECAUSE HE FELT UNCOMFORTABLE AFTER EATING. FRACTURE DUE TO LOAD. THERE IS NO HEALTH HAZARD. EXCESSIVE LOAD. TOOTH SITE # 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14315946 ↗InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED FRACTURE OF THE ALVEOLUS WALL DURING IMPLANT PLACEMENT . THE DOCTOR ALSO REPORTED BONE LOSS. PROCEDURE WAS NOT COMPLETED.
Patient problems: Bone Fracture(s); Osteolysis
MAUDE report 13597396 ↗MalfunctionNov 27, 2021Fracture; Fracture
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12879855 ↗InjuryJun 18, 2021Adverse 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 12025691 ↗InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THE IMPLANTS IN TOOTH LOCATION #44 AND 46 WERE REMOVED DUE TO PERI-IMPLANTITIS. SITE PRESENTED INFLAMMATION AND PATIENT FELT PAIN.
Patient problems: Implant Pain; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 11640151 ↗InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THE IMPLANTS IN TOOTH LOCATION #44 AND 46 WERE REMOVED DUE TO PERI-IMPLANTITIS. SITE PRESENTED INFLAMMATION AND PATIENT FELT PAIN.
Patient problems: Implant Pain; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 11640129 ↗MalfunctionNov 30, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10918087 ↗InjuryOct 2, 2020Adverse 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: No Code Available; Unspecified Infection
MAUDE report 10618814 ↗InjurySep 7, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10499258 ↗InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT LACKED PRIMARY STABILITY WHEN PLACING AND WAS REMOVED.
Patient problems: No Information
MAUDE report 10435938 ↗InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT LACKED PRIMARY STABILITY WHEN PLACING AND WAS REMOVED.
Patient problems: No Information
MAUDE report 10435831 ↗InjuryAug 19, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10424780 ↗InjuryAug 7, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10377726 ↗InjuryMay 26, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10088265 ↗InjuryMar 25, 2020Fracture; Fracture
IT WAS REPORTED THAT THE NECK PORTION OF THE IMPLANT FRACTURED. IMPLANT WAS COMPLETELY REMOVED.
Patient problems: No Information
MAUDE report 9876939 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page