Tuff TT Implant NM-F4313Recalls & reported problems
Noris Medical Ltd · Tuff TT, D4.2, L13, 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 threaded titanium dental implant used as a root-form replacement for a missing tooth. The 50 reports describe implants that fail to fuse with the surrounding bone and later loosen or become mobile, sometimes with infection, pain, or bone loss around the site; all 50 involve injuries and no deaths are reported. 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
- 50
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 07290108812275), received between May 2, 2024 and May 27, 2026 — classified as 50 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (22 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 Osseointegrate22
- Loosening of Implant Not Related to Bone-Ingrowth21
- Loss of Osseointegration4
- Insufficient Device Problem Information3
Patient problems
- Failure of Implant37
- Unspecified Infection12
- Implant Pain6
- Osteolysis4
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025. ON (B)(6) 2026, 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 25300531 ↗InjuryMay 27, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025. ON (B)(6) 2026, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. 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 25300522 ↗InjuryMay 27, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025. ON (B)(6) 2026, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. 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 25297640 ↗InjuryMay 27, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025. ON (B)(6) 2026, 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 25297636 ↗InjuryApr 27, 2026Loosening 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. 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 24997064 ↗InjuryApr 27, 2026Loosening 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. 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 24994965 ↗InjuryMar 5, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025. ON (B)(6) 2026, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION, THYROID/LUPIS. 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 24520535 ↗InjuryMar 5, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025. ON (B)(6) 2026, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION, THYROID/LUPIS . 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 24520506 ↗InjuryMar 2, 2026Loosening 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 HAS HYPERTENSION. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. 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; Implant Pain
MAUDE report 24479932 ↗InjuryFeb 23, 2026Loosening 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 HAS HYPERTENSION. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. 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; Implant Pain
MAUDE report 24413499 ↗InjuryNov 9, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2024. 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: INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 23506690 ↗InjuryNov 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) 2024. 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: INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 23485150 ↗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 HAS HYPERTENSION. 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 22408479 ↗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 HAS HYPERTENSION. 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 22394275 ↗InjuryMay 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4313 LOT#9001059 IMPLANT LACKED PRIMARY STABILITY. 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 22017550 ↗InjuryMay 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4313 LOT#9001059 IMPLANT LACKED PRIMARY STABILITY. 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 22017435 ↗InjuryMay 8, 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) 2024. ON (B)(6) 2025 LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED ON TOOTH #4. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. 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; Implant Pain
MAUDE report 21984407 ↗InjuryMay 8, 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) 2024. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED ON TOOTH #4. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. 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; Implant Pain
MAUDE report 21984367 ↗InjuryMay 7, 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) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. 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 21975999 ↗InjuryMay 7, 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 IS SMOKER, THE PATIENT HAS PEN ALLERGY. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. OBSERVED DURING THE EVENT: BONE LOSS, INFECTION, MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant; Implant Pain; Osteolysis; Unspecified Infection
MAUDE report 21975997 ↗InjuryMay 7, 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) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. 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 21975940 ↗InjuryMay 7, 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 IS SMOKER, THE PATIENT HAS PEN ALLERGY. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. OBSERVED DURING THE EVENT: BONE LOSS, INFECTION, MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant; Implant Pain; Osteolysis; Unspecified Infection
MAUDE report 21975937 ↗InjuryApr 28, 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) 2024. ON (B)(6) 2024, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION. 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 21916214 ↗InjuryApr 27, 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) 2024. ON (B)(6) 2024, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION. 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 21915903 ↗InjuryMar 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4313, LOT#9000417, IMPLANT LACKED PRIMARY STABILITY ON TOOTH #12 DUE TO LOW TORQUE. A SECONDARY IMPLANT WAS PLACED AFTER REMOVAL. 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 21582706 ↗
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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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