AVIATOR 48811357Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252152323), received between Jun 12, 2017 and Feb 2, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2024Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS THE MIGRATION OF AN AVIATOR VARIABLE SELF-DRILLING SCREW AT LEFT-SIDE C7. DURING SURGERY, IT WAS DISCOVERED THAT THE LOCKING WING OF THE AVIATOR THREE-LEVEL PLATE WAS FRACTURED AT THAT SAME LEVEL. THIS REPORT CAPTURES THE AVIATOR THREE-LEVEL PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631238 ↗
• InjurySep 24, 2018Device Slipped; Deformation Due to Compressive Stress; Material Protrusion/Extrusion; Deformation Due to Compressive Stress

  PLATE WAS IDENTIFIED WITH 2 LOWEST SCREWS BACKED OUT. PATIENT WAS BROUGHT TO SURGERY TO REMOVE THE TWO PROTRUDING SCREWS. THE 2 SCREWS WERE REMOVED AND THE PLATE REMAINS IMPLANTED.

  Patient problems: Injury; No Code Available

  MAUDE report 7903561 ↗
• MalfunctionJun 12, 2017Break; Device Dislodged or Dislocated; Material Deformation; Material Deformation

  IT WAS REPORTED THAT; SURGEON WAS DOING A 3-6 ACDF WITH A 57MM PLATE. HE INITIALLY PUT ALL 8 SCREWS IN 2/3 OF THE WAY, NOT USING THE DRILL GUIDE. HE TIGHTENED DOWN THE SCREWS AT THE TOP LEVEL AND BOTTOM LEVEL, AND WHEN HE WENT TO TIGHTEN DOWN THE SCREWS AT THE MIDDLE LEVELS, HE NOTICED ONE OF THE WINGS HAD SNAPPED OUT OF THE PLATE. HE BACKED OUT ALL THE SCREWS, DAMAGING SOME OF THE OTHER LOCKING WINGS. A NEW 57MM PLATES WAS INSTALLED SUCCESSFULLY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6635340 ↗