Tuff TT Implant NM-F4316Recalls & reported problems
Noris Medical Ltd · Tuff TT, D4.2, L16, Int. Hex Ti. Implant · Class 2 · Implant
All models of Tuff TT Implant (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Noris Medical Tuff TT is a root-form dental implant used to replace a tooth. The 37 reports mostly describe implants that fail to fuse with the surrounding bone, so they loosen or become mobile, sometimes breaking, with reports also mentioning bone loss and infection. There are 36 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
- 35
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 07290108812282), received between May 5, 2024 and Mar 17, 2026 — classified as 34 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (18 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate18
- Loosening of Implant Not Related to Bone-Ingrowth9
- Loss of Osseointegration5
- Fracture2
- Insufficient Device Problem Information1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Failure of Implant29
- Unspecified Infection8
- Osteolysis6
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS REPORTED. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. OBSERVED DURING THE EVENT: BONE LOSS/MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24618846 ↗InjuryMar 15, 2026Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS REPORTED. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. OBSERVED DURING THE EVENT: BONE LOSS/MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24601615 ↗InjuryMar 2, 2026Fracture; Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, IMPLANT FRACTURE WAS VERIFIED. OBSERVED DURING THE EVENT: IMPLANT FRACTURE/ BONE LOSS/INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 24483421 ↗InjuryMar 2, 2026Fracture
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, IMPLANT FRACTURE WAS VERIFIED. OBSERVED DURING THE EVENT: IMPLANT FRACTURE/ BONE LOSS/INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 24482921 ↗InjuryNov 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 . ON (B)(6) 2025 , LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS A HEALTHY. OBSERVED DURING THE EVENT: MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant
MAUDE report 23645209 ↗InjuryNov 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. OBSERVED DURING THE EVENT: MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant
MAUDE report 23631103 ↗InjuryJul 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER. OBSERVED DURING THE EVENT: INFECTION, MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22408476 ↗InjuryJul 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER. OBSERVED DURING THE EVENT: INFECTION, MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22394278 ↗InjuryJun 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. OBSERVED DURING THE EVENT: MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant
MAUDE report 22283550 ↗InjuryJun 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. OBSERVED DURING THE EVENT: MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant
MAUDE report 22279489 ↗InjuryApr 17, 2025Loss of Osseointegration; Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS REPORTED. ACCORDING TO THE INFORMATION, THE PATIENT HAS BRUXISM. OBSERVED DURING THE EVENT: BONE LOSS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Osteolysis
MAUDE report 21855976 ↗InjuryApr 17, 2025Loss of Osseointegration; Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS REPORTED. ACCORDING TO THE INFORMATION, THE PATIENT HAS BRUXISM. OBSERVED DURING THE EVENT: BONE LOSS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Osteolysis
MAUDE report 21855673 ↗InjuryMar 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4216, LOT#9000765, IMPLANT LACKED PRIMARY STABILITY. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21558798 ↗InjuryFeb 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4316 LOT# 9000959 IMPLANT LACKED PRIMARY STABILITY DUE TO LOW TORQUE, SOFT BONE. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER, THE PATIENT HAS DIABETES. AT THE EVENT, THE PATIENT EXPERIENCED: INFECTION, BONE LOSS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21419954 ↗InjuryFeb 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4316 LOT# 9000959 IMPLANT LACKED PRIMARY STABILITY DUE TO LOW TORQUE, SOFT BONE. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER, THE PATIENT HAS DIABETES. AT THE EVENT, THE PATIENT EXPERIENCED: INFECTION, BONE LOSS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21419828 ↗InjuryFeb 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 . ON (B)(6) 2024 , LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. OBSERVED DURING THE EVENT: INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 21373525 ↗InjuryJan 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023. ON (B)(6) 2024, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. OBSERVED DURING THE EVENT: INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 21236983 ↗InjuryOct 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4316 LOT#9000903 IMPLANT LACKED PRIMARY STABILITY. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 20489822 ↗InjuryOct 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4316 LOT#9000959 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #4. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 20379898 ↗InjuryOct 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4316 LOT#: 9000959 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #13. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT HAS DIABETES. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 20379897 ↗InjurySep 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT BONE TOO SOFT AND NM-F4316 LOT#9000903 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #5. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 20300366 ↗InjurySep 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4316 LOT#9000675 IMPLANT LACKED PRIMARY. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 20165506 ↗InjurySep 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024. ON (B)(6) 2024, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. OBSERVED DURING THE EVENT: NO INTEGRATION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant
MAUDE report 20165503 ↗InjuryJul 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4316 LOT#9000903 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #13. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 19847989 ↗InjuryJul 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4316 LOT#9000675 IMPLANT LACKED PRIMARY STABILITY. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER. OBSERVED DURING THE EVENT: BONE LOSS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 19788553 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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