Zygomatic Implant NM-F4457Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07290108812404), received between May 20, 2024 and Sep 17, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• 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. 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 50800960 ↗
• 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 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 50788985 ↗
• InjuryAug 13, 2024Failure to Osseointegrate; Failure to Osseointegrate

  A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4457 LOT#0025758 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #5. 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 19971663 ↗
• InjuryJul 23, 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) 2024. ON (B)(6) 2024, 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. 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 19803655 ↗
• InjuryMay 21, 2024Failure to Osseointegrate; Failure to Osseointegrate

  A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4457 LOT#0025758 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 A SMOKER. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19358488 ↗
• InjuryMay 21, 2024Failure to Osseointegrate; Failure to Osseointegrate

  A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4457 LOT#0023950 IMPLANT LACKED PRIMARY STABILITY. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT HAS SINUS PROBLEMS, ARTHRITS, CONGENITAL HEART DISEASE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19358481 ↗
• InjuryMay 20, 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) 2024, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. HOWEVER, ON IMPLANTATION DATE THE IMPLANT HAS BEEN EXPIRED. ACCORDING TO THE INFORMATION, THE PATIENT HAS STEROID THERAPY, TMJ DISORDER, ANEMIC. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. OBSERVED DURING THE EVENT: INFECTION, INFLAMMATION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

  Patient problems: Implant Pain; Inflammation; Unspecified Infection

  MAUDE report 19350522 ↗