AVIATOR 48811232Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613252152200), received between Mar 17, 2016 and Feb 17, 2022 — classified as 1 injury, 5 malfunctions.

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SPRING BAR OF AN AVIATOR TWO LEVEL PLATE FRACTURED AND A SCREW MIGRATED POST-OPERATIVELY. THE PATIENT WILL BE MONITORED AND REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549032 ↗
• InjuryApr 10, 2019Break; Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE EXPLORATORY SURGERY DUE TO DISCOMFORT IN PATIENT'S THROAT, THE LOCKING MECHANISM OF THE PLATE WAS FOUND TO BE BROKEN AND CAUSED LACERATION TO THE ESOPHAGUS MUSCLE WHICH IN TURN HAD TO BE SEWN CLOSED. THE BROKEN PLATE WAS REPLACED. THIS PROCESS RESULTED IN SIGNIFICANT SURGICAL DELAY. HOWEVER, THE EXACT DURATION OF THE SURGICAL DELAY WAS NOT REPORTED.

  Patient problems: Discomfort; Feeding Problem; Laceration(s); Laceration(s) of Esophagus

  MAUDE report 8499068 ↗
• MalfunctionOct 9, 2018Break; Material Deformation; Material Deformation

  SURGEON WAS PERFORMING A C5-C7 ACDF WITH THE PLATE SYSTEM. SURGEON WAS TIGHTENING A 4.35 SELF TAPPING SCREW AT C7 WHEN A SPRING BAR AT C5 POPPED UP. SURGEON REMOVED THAT PLATE AND APPLIED ANOTHER TO FINISH THE CASE. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7950394 ↗
• MalfunctionJul 19, 2016Disconnection

  PER REPORTED EVENT; SURGEON ATTEMPTED TO IMPLANT A 32MM 2 LEVEL PLATE WITH 4.35MM RESCUE SCREWS AND THE METAL LOCKING HINGE CAME DISCONNECTED FROM THE PLATE. SURGEON TOOK PLATE OUT AND INSERTED A NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5804237 ↗
• MalfunctionMay 23, 2016Bent; Material Deformation

  IT WAS REPORTED THAT; PLATE WAS BENT AND IMPLANTED INTO THE PATIENT. AFTER SURGEON TOOK AN XRAY AND UPON CLOSING, SURGEON NOTICED THE SILVER LOCKING MECHANISM WAS DEFORMED. TOOK THE PLATE OUT AND REPLACED WITH THE SAME SIZE PLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5673191 ↗
• MalfunctionMar 17, 2016Material Deformation; Material Integrity Problem; Detachment Of Device Component; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE DOCTOR WENT TO BACK A SCREW FROM THE PLATE AND THE EYELID CAME OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5509286 ↗