Tuff TT ImplantRecalls & reported problems across all models
Noris Medical Ltd · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 299
- Deaths reported
- 0
- Injuries reported
- 297
- Recalls
- 0
We found 15 models of Tuff TT Implant by Noris Medical Ltd in the FDA's device registry (GUDID). Together they are named in 299 adverse event reports in the FDA's MAUDE database, received between May 2, 2024 and Aug 25, 2026 — classified as 297 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (144 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Tuff TT Implant problems
Device problems
- Failure to Osseointegrate144
- Loosening of Implant Not Related to Bone-Ingrowth100
- Loss of Osseointegration42
- Insufficient Device Problem Information10
- Fracture2
- Manufacturing, Packaging or Shipping Problem2
Patient problems
- Failure of Implant244
- Unspecified Infection62
- Implant Pain55
- Osteolysis43
- Insufficient Information11
- Inflammation2
- No Clinical Signs, Symptoms or Conditions1
Tuff TT Implant models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tuff TT Implant NM-F4313Implant, Endosseous, Root-Form50 reports
- Tuff TT Implant NM-F5108Implant, Endosseous, Root-Form41 reports
- Tuff TT Implant NM-F5110Implant, Endosseous, Root-Form39 reports
- Tuff TT Implant NM-F4316Implant, Endosseous, Root-Form35 reports
- Tuff TT Implant NM-F4310Implant, Endosseous, Root-Form28 reports
- Tuff TT Implant NM-F4308Implant, Endosseous, Root-Form25 reports
- Tuff TT Implant NM-F4311Implant, Endosseous, Root-Form22 reports
- Tuff TT Implant NM-F5113Implant, Endosseous, Root-Form18 reports
- Tuff TT Implant NM-F6110Implant, Endosseous, Root-Form12 reports
- Tuff TT Implant NM-F5111Implant, Endosseous, Root-Form9 reports
- Tuff TT Implant NM-F6108Implant, Endosseous, Root-Form8 reports
- Tuff TT Implant NM-F4318Implant, Endosseous, Root-Form6 reports
- Tuff TT Implant NM-F5116Implant, Endosseous, Root-Form3 reports
- Tuff TT Implant NM-F6111Implant, Endosseous, Root-Form2 reports
- Tuff TT Implant NM-F4320Implant, Endosseous, Root-Form1 report
Recent Tuff TT Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 25, 2026Loss of Osseointegration
The healthcare professional reports the implant was inserted (b)(6) (2026) in the patient's mouth. On (b)(6) (2026), loss of osseointegration was reported. According to the information, the patient is Healthy. The Doctor wrote that the implant fell out at home and a patient brought into a Clinic. 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 50426223 ↗InjuryAug 23, 2026Loss of Osseointegration
Patient problems: Osteolysis
MAUDE report 50394913 ↗InjuryAug 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 has Diabetes. At the event, the patient experienced: Pain. 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; Implant Pain; Unspecified Infection
MAUDE report 50394908 ↗InjuryJun 23, 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. 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 25593203 ↗InjuryJun 14, 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 PERIODONTITIS/BRUXISM. 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 25497352 ↗InjuryJun 2, 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. 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 25357590 ↗InjuryJun 2, 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 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 25357586 ↗InjuryJun 2, 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/INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25357580 ↗InjuryJun 1, 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/INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25354759 ↗InjuryJun 1, 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 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 25349380 ↗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 ↗
Other Noris Medical Ltd products
All Noris Medical Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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