Tuff Implant NM-F3713Recalls & reported problems
Noris Medical Ltd · Tuff, D3.75, 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 implant has 87 reports in the FDA database, with no deaths and 85 injuries. Many reports describe the implant losing or failing to integrate with the bone, with bone loss and loosening, and some describe infection or pain. Reports rose to 44 in the past 12 months from 22 the year before. 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
- 86
- Deaths reported
- 0
- Injuries reported
- 84
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 07290108812114), received between May 2, 2024 and Jul 9, 2026 — classified as 84 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (32 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-Ingrowth32
- Loss of Osseointegration27
- Failure to Osseointegrate23
- Fracture2
- Insufficient Device Problem Information2
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Failure of Implant62
- Unspecified Infection30
- Osteolysis27
- Implant Pain24
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2026Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 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. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Osteolysis
MAUDE report 25764525 ↗InjuryJul 9, 2026Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 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. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Osteolysis
MAUDE report 25764507 ↗InjuryJul 9, 2026Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS REPORTED. ACCORDING TO THE INFORMATION, THE PATIENT IS A HEALTHY. 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 25764503 ↗InjuryJul 8, 2026Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 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. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Osteolysis
MAUDE report 25748199 ↗InjuryJul 8, 2026Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS REPORTED. ACCORDING TO THE INFORMATION, THE PATIENT IS A HEALTHY. 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 25748198 ↗InjuryJun 22, 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 HAS OSTEOPOROSIS, BISPHOSPHONATE HISTORY. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. OBSERVED DURING THE EVENT: BONE LOSS/MOBILITY/INFECTION. 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 25577165 ↗InjuryJun 22, 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 HAS OSTEOPOROSIS, BISPHOSPHONATE HISTORY. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. OBSERVED DURING THE EVENT: BONE LOSS/MOBILITY/INFECTION. 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 25574206 ↗InjuryMay 25, 2026Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS REPORTED. ACCORDING TO THE INFORMATION, THE PATIENT IS A HEALTHY. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. OBSERVED DURING THE EVENT: BONE LOSS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Implant Pain; Osteolysis
MAUDE report 25268296 ↗InjuryMay 25, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026. 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: INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 25268293 ↗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 25268290 ↗InjuryMay 25, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026. 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: INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 25268287 ↗InjuryMay 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 IS A HEALTHY/SMOKER. 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 25265177 ↗InjuryMay 23, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026. 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: INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 25264803 ↗InjuryMay 23, 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. 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 25264802 ↗InjuryMay 23, 2026Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2025 , LOSS OF OSSEOINTEGRATION WAS REPORTED. ACCORDING TO THE INFORMATION, THE PATIENT IS A HEALTHY. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. OBSERVED DURING THE EVENT: BONE LOSS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Implant Pain; Osteolysis
MAUDE report 25264801 ↗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 25264798 ↗InjuryMay 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 IS A HEALTHY/SMOKER. 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 25264795 ↗InjuryApr 20, 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 HAS BRUXISM. 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 24923192 ↗InjuryApr 19, 2026Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS REPORTED. ACCORDING TO THE INFORMATION, THE PATIENT HAS BRUXISM. 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 24921008 ↗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 A HEALTHY. 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 24618854 ↗InjuryMar 17, 2026Fracture
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. OBSERVED DURING THE EVENT: IMPLANT FRACRURED/ MOBILUTY. THE DOCTOR SAID THAT IMPLANT FAILED AS THE TEMPORARY WENT THROUGH MICROMOVEMENT. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant
MAUDE report 24618853 ↗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 24618847 ↗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 24601618 ↗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. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Osteolysis
MAUDE report 24601617 ↗InjuryMar 15, 2026Fracture; Loosening of Implant Not Related to Bone-Ingrowth
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. OBSERVED DURING THE EVENT: IMPLANT FRACRURED/ MOBILUTY. THE DOCTOR SAID THAT IMPLANT FAILED AS THE TEMPORARY WENT THROUGH MICROMOVEMENT. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant
MAUDE report 24601611 ↗
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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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