Tuff ImplantRecalls & reported problems across all models
Noris Medical Ltd · 33 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 813
- Deaths reported
- 0
- Injuries reported
- 805
- Recalls
- 0
We found 33 models of Tuff Implant by Noris Medical Ltd in the FDA's device registry (GUDID). Together they are named in 813 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2023 and Sep 17, 2026 — classified as 805 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (407 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 Implant problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth407
- Loss of Osseointegration197
- Failure to Osseointegrate158
- Insufficient Device Problem Information34
- Adverse Event Without Identified Device or Use Problem7
- Fracture6
- Manufacturing, Packaging or Shipping Problem6
Patient problems
- Failure of Implant574
- Unspecified Infection225
- Osteolysis193
- Implant Pain153
- Insufficient Information34
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Tuff Implant models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tuff Implant NM-F3713Implant, Endosseous, Root-Form86 reports
- Tuff Implant NM-F4210Implant, Endosseous, Root-Form70 reports
- Tuff Implant NM-F4213Implant, Endosseous, Root-Form68 reports
- Tuff Implant NM-F3711Implant, Endosseous, Root-Form57 reports
- Tuff Implant NM-F5010Implant, Endosseous, Root-Form51 reports
- Tuff Implant NM-F3716Implant, Endosseous, Root-Form50 reports
- Tuff Implant NM-F4216Implant, Endosseous, Root-Form49 reports
- Tuff Implant NM-F4211Implant, Endosseous, Root-Form41 reports
- Tuff Implant NM-F3310Implant, Endosseous, Root-Form38 reports
- Tuff Implant NM-F4208Implant, Endosseous, Root-Form38 reports
- Tuff Implant NM-F5008Implant, Endosseous, Root-Form31 reports
- Tuff Implant NM-F3313Implant, Endosseous, Root-Form29 reports
- Tuff Implant NM-F3710Implant, Endosseous, Root-Form27 reports
- Tuff Implant NM-F3311Implant, Endosseous, Root-Form20 reports
- Tuff Implant NM-F6010Implant, Endosseous, Root-Form20 reports
- Tuff Implant NM-F5013Implant, Endosseous, Root-Form19 reports
- Tuff Implant NM-F3316Implant, Endosseous, Root-Form16 reports
- Tuff Implant NM-F5011Implant, Endosseous, Root-Form16 reports
- Tuff Implant NM-F3708Implant, Endosseous, Root-Form15 reports
- Tuff Implant NM-F3718Implant, Endosseous, Root-Form12 reports
- Tuff Implant NM-F6008Implant, Endosseous, Root-Form10 reports
- Tuff Implant NM-F3308Implant, Endosseous, Root-Form8 reports
- Tuff Implant NM-F4220Implant, Endosseous, Root-Form8 reports
- Tuff Implant NM-F4218Implant, Endosseous, Root-Form7 reports
- Tuff Implant NM-F5016Implant, Endosseous, Root-Form7 reports
- Tuff Implant NM-F6011Implant, Endosseous, Root-Form6 reports
- Tuff Implant NMSF3710Implant, Endosseous, Root-Form2 reports
- Tuff Implant NMSF3713Implant, Endosseous, Root-Form2 reports
- Tuff Implant NMSF4210Implant, Endosseous, Root-Form2 reports
- Tuff Implant NMSF4211Implant, Endosseous, Root-Form2 reports
- Tuff Implant NMSF4216Implant, Endosseous, Root-Form2 reports
- Tuff Implant NM-F4225Implant, Endosseous, Root-Form2 reports
- Tuff Implant NM-F6016Implant, Endosseous, Root-Form2 reports
Recent Tuff Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 17, 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 Healthy. At the event, the patient experienced: Pain. The device was forwarded to the manufacturer. No patient operative or post-operative complications reported.
Patient problems: Implant Pain
MAUDE report 50800959 ↗InjurySep 17, 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 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 50800958 ↗InjurySep 17, 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. At the event, the patient experienced: Pain. The device was forwarded to the manufacturer. No patient operative or post-operative complications reported.
Patient problems: Implant Pain
MAUDE report 50800957 ↗InjurySep 17, 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 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 50800956 ↗InjurySep 17, 2026Loss of Osseointegration
The healthcare professional reports the implant was inserted (b)(6) 2023 in the patient's mouth. On (b)(6) 2026, loss of osseointegration was reported. According to the information, the patient has Hypertension. 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 50800955 ↗InjurySep 16, 2026Loss of Osseointegration
The healthcare professional reports the implant was inserted (b)(6) 2023 in the patient's mouth. On (b)(6) 2026, loss of osseointegration was reported. According to the information, the patient has Hypertension. 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 50788986 ↗InjurySep 16, 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 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 50788984 ↗InjurySep 16, 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 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 50788983 ↗InjurySep 16, 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. At the event, the patient experienced: Pain. The device was forwarded to the manufacturer. No patient operative or post-operative complications reported.
Patient problems: Implant Pain
MAUDE report 50788982 ↗InjurySep 16, 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. At the event, the patient experienced: Pain. The device was forwarded to the manufacturer. No patient operative or post-operative complications reported.
Patient problems: Implant Pain
MAUDE report 50788981 ↗InjurySep 15, 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. 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 50771389 ↗InjurySep 15, 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. 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 50771388 ↗InjurySep 15, 2026Loosening of Implant Not Related to Bone-Ingrowth
The clinician reports the implant was inserted 2026 (b)(6). On 2026 (b)(6), 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 50771387 ↗InjurySep 15, 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. 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 50771338 ↗InjurySep 15, 2026Loosening of Implant Not Related to Bone-Ingrowth
The clinician reports the implant was inserted 2026 (b)(6). On 2026 (b)(6), 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 50771337 ↗
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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