OSSEOTITE® NT411Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® TAPERED 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 NT411 endosseous dental implant, a tapered screw placed into the jawbone to support a replacement tooth. The 67 reports mostly describe implants that loosened or were removed after peri-implantitis, bone loss, infection, pain, and inflammation, and a few mention the implant or its parts fracturing or separating. No deaths were reported; 61 reports involved injuries. There are no recalls naming 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
- 68
- Deaths reported
- 0
- Injuries reported
- 62
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00844868012023), received between Jun 18, 2019 and Jul 30, 2026 — classified as 62 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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 Problem51
- Fracture5
- Patient-Device Incompatibility5
- Mechanical Problem4
- Separation Failure3
- Separation Problem1
Patient problems
- Unspecified Infection32
- Osteolysis30
- Pain15
- Inflammation14
- No Clinical Signs, Symptoms or Conditions12
- No Information11
- No Code Available6
- Hypersensitivity/Allergic reaction5
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported a Periimplantitis at tooth site #36. Implant was removed. Bone Type: III.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50081335 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
The doctor reports that the dental implant failed due to peri-implantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50052081 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25188695 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #45 AND #35 WERE REMOVED DUE TO BONE LOSS. 4 IMPLANTS WERE PLACED FOR HYBRID PROSTHETICS.
Patient problems: Osteolysis
MAUDE report 25172876 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #45 AND #35 WERE REMOVED DUE TO BONE LOSS. 4 IMPLANTS WERE PLACED FOR HYBRID PROSTHETICS.
Patient problems: Osteolysis
MAUDE report 25172718 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #25, #23 AND #14 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24561348 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #25, #23 AND #14 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24561257 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #25, #23 AND #14 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24561122 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #23 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24559805 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 46 WAS REMOVED DUE TO PERI-IMPLANTITIS. FIBROSIS WAS OBSERVED AND THE CROWN ALONG WITH THE IMPLANT WERE REMOVED. BONE DRILLING WAS PERFORMED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND EDEMA.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24455325 ↗InjuryNov 4, 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 TOOTH SITES #14 & #16 FAILED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23466622 ↗InjuryJul 15, 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 POSITION #45 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED: INFLAMMATION, PAIN, EDEMA, ABSCESS.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 22513357 ↗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 #24 & #26 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22191764 ↗InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 26 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22156489 ↗InjuryJan 3, 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 45 HAD MOBILITY AND WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A CONSEQUENCE OF THE EVENT. CURETTAGE WAS PERFORMED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21064722 ↗InjuryDec 2, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain
MAUDE report 20817218 ↗InjuryDec 2, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain
MAUDE report 20817181 ↗InjuryDec 2, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain
MAUDE report 20817157 ↗InjuryDec 2, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain
MAUDE report 20817134 ↗InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BONE LOSS AT TOOTH SITES 12 AND 47. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Pain
MAUDE report 20512013 ↗InjuryAug 27, 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 #24 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: UNKNOWN. THE DOCTOR REPORTED PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 20073575 ↗InjuryAug 22, 2024Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20029226 ↗InjuryJun 11, 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 13 & 16 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. THE DOCTOR ALSO REPORTED INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 19508071 ↗InjuryApr 25, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19181675 ↗InjuryApr 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 19151849 ↗
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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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