Tuff TT Implant NM-F5108Recalls & reported problems
Noris Medical Ltd · Tuff TT, D5.0, L8, 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 Tuff TT endosseous dental implant by Noris Medical is a root-form screw implant placed into the jawbone to replace a missing tooth. The 43 adverse event reports mostly describe implants that fail to fuse with the bone or later loosen and become mobile, sometimes falling out, along with pain, infection, and bone loss. No deaths were reported, but 43 injuries were. There are no recalls naming this device, and reports have dropped from 24 in the prior 12 months to 9 in the last 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
- 41
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 07290108812480), received between May 7, 2024 and Aug 25, 2026 — classified as 41 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (19 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 Osseointegrate19
- Loosening of Implant Not Related to Bone-Ingrowth16
- Loss of Osseointegration6
Patient problems
- Failure of Implant34
- Implant Pain8
- Osteolysis6
- Unspecified Infection6
Recent adverse event reports
The 25 most recent of 41 reports, 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 ↗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 ↗InjuryJan 12, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 . ON (B)(6) 2025 , 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 24033659 ↗InjuryJan 12, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 . ON (B)(6) 2025 , 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 24032618 ↗InjuryNov 4, 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/ DIABETES/ OZEMPIC HOLD. 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 23464979 ↗InjuryNov 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/ DIABETES/ OZEMPIC HOLD. 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 23449974 ↗InjurySep 2, 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/DIABETES. 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 22932267 ↗InjuryAug 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/DIABETES. 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 22911353 ↗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 22839928 ↗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 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 22826402 ↗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) 2024. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS A 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 22283473 ↗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) 2024. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS A 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 22279498 ↗InjuryMay 15, 2025Loss of Osseointegration; Loss 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 SMOKER. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. 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; Implant Pain; Osteolysis
MAUDE report 22024837 ↗InjuryMay 15, 2025Loss of Osseointegration; Loss 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 SMOKER. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. 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; Implant Pain; Osteolysis
MAUDE report 22024682 ↗InjuryMay 14, 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. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. 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; Implant Pain; Unspecified Infection
MAUDE report 22017548 ↗InjuryMay 14, 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. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. 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; Implant Pain; Unspecified Infection
MAUDE report 22017452 ↗InjuryMay 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F5108 LOT # 9001058 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. AT THE EVENT, THE PATIENT EXPERIENCED: BONE LOSS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21984431 ↗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. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. OBSERVED DURING THE EVENT: INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 21984409 ↗InjuryMay 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F5108, LOT#9001058 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. AT THE EVENT, THE PATIENT EXPERIENCED: BONE LOSS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21984382 ↗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. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. OBSERVED DURING THE EVENT: INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 21984378 ↗InjuryApr 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F5108 LOT#9001058 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #14 DUE TO BONE TOO SOFT. 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 SMOKER, THE PATIENT HAS THYROID THERAPY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21738539 ↗InjuryApr 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F5108, LOT#9001058, IMPLANT LACKED PRIMARY STABILITY ON TOOTH #14 DUE TO BONE TOO SOFT. 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 SMOKER, THE PATIENT HAS THYROID THERAPY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21738420 ↗InjuryMar 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F5108 LOT#9001058 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #10 DUE TO BONE TOO SOFT. 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 HAS HYPERTENSION, THYROID THERAPY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21729436 ↗InjuryMar 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F5108 LOT#9001058 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #10 DUE TO BONE TOO SOFT. 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 HAS HYPERTENSION, THYROID THERAPY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21729376 ↗
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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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