Zygomatic Implant NM-F4445Recalls & reported problems
Noris Medical Ltd · Zygomatic, D4.2, L45, Int. Hex Ti. Implant · Class 2 · Implant
All models of Zygomatic Implant (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Noris Medical zygomatic implant is a titanium screw-shaped dental implant anchored into the cheekbone rather than the jawbone. The 38 reports mostly describe implants that fail to fuse with the surrounding bone or that loosen later, with patients reporting pain, swelling and infection. There are 37 injuries and no deaths, and no recalls name this device. Reports fell from 16 in the earlier 12 months to 6 in the most recent.
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
- 35
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 07290108812350), received between Nov 16, 2023 and Jun 2, 2026 — classified as 34 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (22 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 Osseointegrate22
- Loosening of Implant Not Related to Bone-Ingrowth11
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant24
- Implant Pain7
- Unspecified Infection3
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
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. ACCORDING TO THE INFORMATION, THE PATIENT HAS A BLOOD PRESSURE ISSUES. 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 25357584 ↗InjuryFeb 2, 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. ACCORDING TO THE INFORMATION, THE PATIENT IS A HEALTHY. OBSERVED DURING THE EVENT: PAIN. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Implant Pain
MAUDE report 24233022 ↗InjuryJan 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. ACCORDING TO THE INFORMATION, THE PATIENT IS A HEALTHY. OBSERVED DURING THE EVENT: PAIN. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Implant Pain
MAUDE report 24186791 ↗InjuryMay 15, 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: INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 22026232 ↗InjuryMay 15, 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: INFECTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 22024681 ↗InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445, LOT#0027898 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #13. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION, OSTEOPOROSIS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21959593 ↗InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0027898 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #4. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION, OSTEOPOROSIS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21959589 ↗InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0027898 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #4. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION, OSTEOPOROSIS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21959562 ↗InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445, LOT#0027898 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #13. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION, OSTEOPOROSIS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21959561 ↗InjuryApr 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0028659 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 21917611 ↗InjuryApr 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0028659 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 21917538 ↗InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0029020 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #2. A SECONDARY LONGER IMPLANT WAS PLACED AFTER REMOVAL TO ACHIEVE 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 21706183 ↗InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0028659 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #4. 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 HEALTHY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21706181 ↗InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0028659 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #4. 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 HEALTHY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21706126 ↗InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0029020 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #2. A SECONDARY LONGER IMPLANT WAS PLACED AFTER REMOVAL TO ACHIEVE 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 21706124 ↗InjuryMar 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445, LOT#0027898, 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 SMOKER. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21591613 ↗InjuryMar 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0027898 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 SMOKER. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21591569 ↗InjuryMar 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0028659 IMPLANT LACKED PRIMARY STABILITY. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21558804 ↗InjuryMar 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445, LOT#0028659 IMPLANT LACKED PRIMARY STABILITY. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21558611 ↗InjuryAug 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0026768 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #3. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 19971667 ↗InjuryAug 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0020112 IMPLANT LACKED PRIMARY STABILITY DUE TO LOW TORQUE. 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 19917152 ↗InjuryJul 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0023757 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #1. 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 19788544 ↗InjuryJul 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4445 LOT#0024972 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #2 DUE TO LOW TORQUE. 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 19686214 ↗InjuryJun 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS ON (B)(6) 2024, 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 19640808 ↗InjuryJun 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023. ON (B)(6) 2023, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS A SMOKER, THE PATIENT HAS BRUXISM. 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 19613855 ↗
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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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