Tuff Implant NM-F3313Recalls & reported problems
Noris Medical Ltd · Tuff, D3.3, L13, Int. Hex Ti. Implant · Class 2 · Implant
All models of Tuff Implant (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Noris Medical Tuff endosseous dental implant is a root-form screw placed in the jaw. Most of the 28 reports describe the implant becoming mobile or loosening after it failed to fuse with the surrounding bone, often alongside infection at the site. There are no deaths, 27 injuries, and 1 malfunction. No recalls name this device. Reports mentioning it fell from 10 in the prior 12 months to 4 in the most recent 12 months.
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
- 29
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07290108812053), received between May 26, 2024 and Jul 27, 2026 — classified as 28 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth18
- Failure to Osseointegrate4
- Insufficient Device Problem Information4
- Loss of Osseointegration2
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Failure of Implant22
- Unspecified Infection10
- Insufficient Information5
- Osteolysis2
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Loosening of Implant Not Related to Bone-Ingrowth
The clinician reports the implant was inserted on (b)(6)2026. On (b)(6)2026, 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 50035745 ↗InjuryMay 25, 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: MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant
MAUDE report 25268289 ↗InjuryMay 23, 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 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 25264793 ↗InjuryJan 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. ACCORDING TO THE INFORMATION, THE PATIENT HAS CANCER. OBSERVED DURING THE EVENT: MOBILITY/INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24189000 ↗InjuryJan 25, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2025. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT HAS CANCER. OBSERVED DURING THE EVENT: MOBILITY/INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24175493 ↗InjuryAug 19, 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 22839859 ↗InjuryAug 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 22826387 ↗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) 2025. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED ON TOOTH #26. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER, THE PATIENT HAS HYPERTENSION, DIABETES. 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 21984428 ↗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) 2025 . ON (B)(6) 2025 , LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED ON TOOTH #7. ACCORDING TO THE INFORMATION,THE PATIENT IS SMOKER, THE PATIENT HAS HYPERTENSION, DIABETES. 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 21984427 ↗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) 2025. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED ON TOOTH #20. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER, THE PATIENT HAS HYPERTENSION, DIABETES. 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 21984415 ↗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) 2025. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED ON TOOTH #20. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER, THE PATIENT HAS HYPERTENSION, DIABETES. 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 21984380 ↗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) 2025. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED ON TOOTH #7. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER, THE PATIENT HAS HYPERTENSION, DIABETES. 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 21984377 ↗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) 2025. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED ON TOOTH #26. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER, THE PATIENT HAS HYPERTENSION, DIABETES. 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 21984370 ↗InjuryFeb 20, 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 TAKES ANTIDEPRESSANT. OBSERVED DURING THE EVENT: BONE LOSS, INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21419948 ↗InjuryFeb 20, 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 TAKES ANTIDEPRESSANT. OBSERVED DURING THE EVENT: BONE LOSS, INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21419830 ↗InjurySep 23, 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: MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant
MAUDE report 20276866 ↗MalfunctionAug 15, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F3313 LOT#9000730 IMPLANT WAS OPENED IN THE PACKAGE. THE IMPLANTS WASN'T USED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 19989280 ↗InjuryJul 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F3313 LOT#9000730 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 DIABETES. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 19788545 ↗InjuryJul 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F3313 LOT#9000730 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 19768594 ↗InjuryJul 10, 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. ACCORDING TO THE INFORMATION, THE PATIENT HAS BRUXISM. 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 19708931 ↗InjuryJul 10, 2024Loosening 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) 2024, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS A SMOKER. 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 19708921 ↗InjuryJul 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A HEALTH PROFESSIONAL REPORTS THE IMPLANT FAILED, HOWEVER BASED ON THE AVAILABLE INFORMATION THE EXACT ISSUE COULD NOT BE IDENTIFIED.
Patient problems: Insufficient Information
MAUDE report 19642776 ↗InjuryJul 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A HEALTH PROFESSIONAL REPORTS THE IMPLANT FAILED, HOWEVER BASED ON THE AVAILABLE INFORMATION THE EXACT ISSUE COULD NOT BE IDENTIFIED.
Patient problems: Insufficient Information
MAUDE report 19642767 ↗InjuryJul 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A HEALTH PROFESSIONAL REPORTS THE IMPLANT FAILED, HOWEVER BASED ON THE AVAILABLE INFORMATION THE EXACT ISSUE COULD NOT BE IDENTIFIED
Patient problems: Insufficient Information
MAUDE report 19642758 ↗InjuryJun 27, 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) 2023. ON (B)(6) 2024, 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 19622673 ↗
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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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