AVIATOR 48811226Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613252152170), received between Mar 27, 2017 and Jun 10, 2020 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 10, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN AVIATOR SCREW MIGRATED OUT OF A DEFORMED AVIATOR ASSY TWO LEVEL PLATE POST-OPERATIVELY. THE PATIENT WAS EXPERIENCING DYSPHAGIA AND THE SURGEON NOTICED THE SCREW HAD MIGRATED VIA X-RAY IMAGING. REVISION SURGERY WAS PERFORMED AND THE SCREW AND PLATE WERE REPLACED. THIS REPORT REPRESENTS THE PLATE.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 10141152 ↗
• MalfunctionJan 2, 2019Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE LOCKING SPRING OF THE PLATE BROKE INTRA-OP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH BACK-UP PLATE. A SURGICAL DELAY OF 5-10 MIN WAS REPORTED. NO ADVERSE CONSEQUENCES TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8207848 ↗
• InjuryAug 20, 2018Material Protrusion/Extrusion; Appropriate Device Problem Term/Code Not Available; Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED TO REMOVE AN ANTERIOR CERVICAL PLATE BECAUSE THE SPRING BAR HAD PROTRUDED OUTWARD INTO THE PATIENT'S ESOPHAGUS CAUSING PAIN. THE PLATE AND SCREWS WERE REMOVED AND REPLACED WITH ANOTHER CERVICAL PLATE.

  Patient problems: Injury; Pain

  MAUDE report 7796611 ↗
• InjuryAug 28, 2017Fracture; Material Integrity Problem; Break; Fracture; Device Slipped; Material Integrity Problem

  IT WAS REPORTED THAT; SCREW BACKED OUT AT BOTTOM LEVEL AND WING WAS BROKEN AND SCREW STARTING TO BACK OUT ON TOP LEVEL. PATIENT REQUIRED REVISION AND WAS SENT TO ENT TO SEE IF THERE WAS ANY DAMAGE TO THE ESOPHAGUS.

  Patient problems: Injury; No Code Available

  MAUDE report 6824046 ↗
• MalfunctionMar 27, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; PLATE SPRINGBAR BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6437693 ↗