Tuff UniCon ImplantRecalls & reported problems across all models
Noris Medical Ltd · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 84
- Deaths reported
- 0
- Injuries reported
- 82
- Recalls
- 0
We found 18 models of Tuff UniCon Implant by Noris Medical Ltd in the FDA's device registry (GUDID). Together they are named in 84 adverse event reports in the FDA's MAUDE database, received between Apr 30, 2025 and Aug 31, 2026 — classified as 82 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (58 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 UniCon Implant problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth58
- Loss of Osseointegration18
- Failure to Osseointegrate6
- Manufacturing, Packaging or Shipping Problem2
Patient problems
- Failure of Implant64
- Implant Pain37
- Unspecified Infection21
- Osteolysis18
Tuff UniCon Implant models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tuff UniCon Implant NMCF4213Implant, Endosseous, Root-Form11 reports
- Tuff UniCon Implant NMCF3710Implant, Endosseous, Root-Form10 reports
- Tuff UniCon Implant NMCF5010Implant, Endosseous, Root-Form8 reports
- Tuff UniCon Implant NMCF3713Implant, Endosseous, Root-Form7 reports
- Tuff UniCon Implant NMCF4211Implant, Endosseous, Root-Form7 reports
- Tuff UniCon Implant NMCF3513Implant, Endosseous, Root-Form7 reports
- Tuff UniCon Implant NMCF5008Implant, Endosseous, Root-Form6 reports
- Tuff UniCon Implant NMCF4210Implant, Endosseous, Root-Form4 reports
- Tuff UniCon Implant NMCF4216Implant, Endosseous, Root-Form4 reports
- Tuff UniCon Implant NMCF5011Implant, Endosseous, Root-Form4 reports
- Tuff UniCon Implant NMCF3708Implant, Endosseous, Root-Form2 reports
- Tuff UniCon Implant NMCF3711Implant, Endosseous, Root-Form2 reports
- Tuff UniCon Implant NMCF3716Implant, Endosseous, Root-Form2 reports
- Tuff UniCon Implant NMCF4208Implant, Endosseous, Root-Form2 reports
- Tuff UniCon Implant NMCF3211Implant, Endosseous, Root-Form2 reports
- Tuff UniCon Implant NMCF3516Implant, Endosseous, Root-Form2 reports
- Tuff UniCon Implant NMCF5508Implant, Endosseous, Root-Form2 reports
- Tuff UniCon Implant NMCF5510Implant, Endosseous, Root-Form2 reports
Recent Tuff UniCon Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 31, 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 has Diabetes/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 50515288 ↗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. 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 50426267 ↗InjuryAug 24, 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. 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 50404996 ↗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. 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 50035740 ↗InjuryJul 27, 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/Mobility. The device was forwarded to the manufacturer. No patient operative or post-operative complications reported.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 50024217 ↗InjuryJul 14, 2026Loss of Osseointegration
THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED ON (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. 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 25811846 ↗InjuryJul 6, 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. 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 25717568 ↗InjuryJun 2, 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: MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant
MAUDE report 25358514 ↗InjuryJun 2, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026. ON (B)(6) 2026, THE IMPLANT WAS NOT OSSEOINTEGRATED. LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS A HEALTHY/SMOKER. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant
MAUDE report 25357591 ↗InjuryJun 1, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026. ON (B)(6) 2026, THE IMPLANT WAS NOT OSSEOINTEGRATED. LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS A HEALTHY/SMOKER. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Failure of Implant
MAUDE report 25354770 ↗InjuryJun 1, 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. 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 25349385 ↗InjuryMay 27, 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 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 25300526 ↗InjuryMay 27, 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. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION. 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 25300523 ↗InjuryMay 27, 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 25300515 ↗InjuryMay 27, 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 25300514 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page