Zygomatic Implant NM-F4452Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07290108812381), received between May 9, 2024 and Apr 19, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 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 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 24921064 ↗
• InjuryApr 16, 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 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 24895106 ↗
• InjuryApr 28, 2025Failure to Osseointegrate; Failure to Osseointegrate

  A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4452 LOT#0025022 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 21917608 ↗
• InjuryApr 28, 2025Failure to Osseointegrate; Failure to Osseointegrate

  A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4452 LOT#0025022 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 21917530 ↗
• InjuryOct 13, 2024Failure to Osseointegrate; Failure to Osseointegrate

  A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4452 LOT#0022398 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 20435713 ↗
• InjurySep 1, 2024Failure to Osseointegrate; Failure to Osseointegrate

  A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4452 LOT#0026704 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 20115344 ↗
• InjuryMay 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A HEALTH PROFESSIONAL REPORTS THE IMPLANT FAILED, HOWEVER BASED ON THE AVAILABLE INFORMATION THE EXACT ISSUE COULD NOT BE IDENTIFIED.

  Patient problems: Insufficient Information

  MAUDE report 19276735 ↗