Tuff Implant NM-F6011Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07290108812565), received between Mar 19, 2025 and Mar 24, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 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: MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 24674502 ↗
• InjuryMar 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. 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 24662444 ↗
• InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate

  A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F6011 LOT#9000287 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. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 21706184 ↗
• InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate

  A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F6011 LOT#9000287 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. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 21706123 ↗
• InjuryMar 19, 2025Loss of Osseointegration; Loss of Osseointegration

  THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS REPORTED ON TOOTH #15. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION. OBSERVED DURING THE EVENT: BONE LOSS, MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

  Patient problems: Osteolysis

  MAUDE report 21640996 ↗
• InjuryMar 19, 2025Loss of Osseointegration; Loss of Osseointegration

  THE HEALTHCARE PROFESSIONAL REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS REPORTED ON TOOTH #15. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION. 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 21640746 ↗