NA 55-07767Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540366160), received between May 23, 2023 and Jun 16, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PLATE WAS BROKEN AND A REVISION SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144218 ↗
• InjuryJun 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PLATE WAS BROKEN AND A REVISION SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144217 ↗
• MalfunctionJun 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PLATES WERE DISCOVERED TO BE BROKEN AND A REVISION SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135951 ↗
• InjuryMay 23, 2023Fracture; Fracture

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT UPON RE-OPERATION TO EXPLANT THE PLATES DUE TO THE MAXILLA SHIFTING, IT WAS DISCOVERED THAT THE PLATES WERE FRACTURED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16987432 ↗
• InjuryMay 23, 2023Fracture; Fracture

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT UPON RE-OPERATION TO EXPLANT THE PLATES DUE TO THE MAXILLA SHIFTING, IT WAS DISCOVERED THAT THE PLATES WERE FRACTURED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16987323 ↗