NA 78-92008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327370881), received between Dec 21, 2021 and Apr 28, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT IT WAS DISCOVERED POST-OPERATIVELY, THAT THE PLATE WAS BROKEN. THERE WAS A SECOND SURGERY PERFORMED TO REMOVE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16833902 ↗
• MalfunctionDec 21, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD BROKEN FACIAL ID PLATES REMOVED AND REPLACED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052590 ↗