AVIATOR 48811234Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613252152217), received between Feb 16, 2016 and Sep 15, 2021 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT WHILE EXPLANTING AN AVIATOR PLATE DURING A REVISION ACDF PROCEDURE, APPROXIMATELY 3 YEARS AFTER INDEX SURGERY, THE LOCKING MECHANISM OF THE PLATE WAS OBSERVED TO BE BROKEN. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON ALSO STATES THAT ONE AVIATOR VARIABLE SCREW HAD MIGRATED AT C6, THE LEVEL WHERE THE LOCKING MECHANISM OF THE PLATE FRACTURED. THE PATIENT WAS REVISED TO REMOVE THE CONSTRUCT. THIS RECORD CAPTURES THE FRACTURED LOCKING MECHANISM OF THE AVIATOR PLATE.

  Patient problems: Dysphagia/ Odynophagia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12477518 ↗
• MalfunctionApr 16, 2019Material Deformation

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR 1 LEVEL ACDF REVISION PROCEDURE DUE TO DEGENERATIVE DISC DISEASE. RIGHT BEFORE THE PROCEDURE, X-RAY REVIEW REVEALED THAT LOCKING RING OF THE PLATE FROM PREVIOUS SURGERY HAS DEFORMED. THEREFORE, THE SURGEON REPLACED THE PLATE AND SCREWS DURING REVISION SURGERY AND THIS RESULTED IN 30 MINUTES SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8518412 ↗
• InjurySep 29, 2017Fracture; Migration or Expulsion of Device; Device Dislodged or Dislocated; Fracture; Migration or Expulsion of Device

  IT WAS REPORTED THAT: PLATE REMOVAL UPDATE 09/06/2017: POST-OP X-RAY SHOWED A SCREW BACKING OUT.

  Patient problems: Injury; No Code Available

  MAUDE report 6904838 ↗
• MalfunctionSep 15, 2017Material Deformation; Material Integrity Problem; Break; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT LOCKING MECHANISM WAS DAMAGED DURING SCREW REMOVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6870057 ↗
• MalfunctionMar 7, 2017Bent; Break; Inadequacy of Device Shape and/or Size; Device Contamination with Chemical or Other Material; Material Integrity Problem; Device Contamination with Chemical or Other Material; Material Integrity Problem

  IT WAS REPORTED THAT; THE SURGEON PERFORMED A C4-6 ACDF AND IMPLANTED A PLATE. AFTER SHOOTING AN XRAY IT WAS DETERMINED THAT A 16MM SCREW IN C4 WAS TOO LONG AND NEEDED TO BE REPLACED WITH A 14MM SCREW. THE SURGEON UTILIZED THE RESCUE DRIVER TO BACK THE SCREW OUT. THE SURGEON INFORMED THE OPERATING ROOM TEAM THAT THE LOCKING SPRING BAR BROKE OFF AS THE SCREW BACKED OUT. CONSEQUENTLY, THE ENTIRE PLATE/SCREW CONSTRUCT HAD TO BE REMOVED AND REPLACED. WHEN REMOVING THE SCREWS FROM C5 THE LOCKING SPRING BAR BENT AT THAT LEVEL AS WELL. THE REP CONFIRMED THAT THE SCREW DRIVER HAD BEEN FULLY ENGAGED IN THE SCREW AND THAT THE LOCKING HUB HAD BEEN IN THE UNLOCKED POSITION PRIOR TO BACKING THE SCREW OUT. THE SURGEON CONFIRMED THAT HE HAD PERFORMED THE REMOVAL PER THE TECHNIQUE. THE PLATE WAS WASHED AND AUTOCLAVED TO BE SENT OFF FOR EVALUATION.

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

  MAUDE report 6384408 ↗
• InjuryNov 21, 2016Fracture; Break; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR A PLATE WITH A BROKEN FLANGE AND SCREW BACKED OUT.

  Patient problems: Injury; No Code Available

  MAUDE report 6119272 ↗
• MalfunctionOct 10, 2016Material Deformation; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED; THAT THE CERVICAL PLATE WAS BEING USED. THE LOCKING NUT WAS ENGAGED ON THE PLATE CAUSING THE SPRING BAR TO BE DAMAGED UPON SCREW INSERTION. ANOTHER 34MM PLATE WAS USED. SCREW IS STILL STUCK IN PLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6015102 ↗
• MalfunctionApr 25, 2016Break; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SURGEON WAS TRYING TO REVISE SCREW IN A PLATE AND SPRING LOCK LOCKING DEVICE BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5606350 ↗
• MalfunctionFeb 16, 2016Mechanical Jam; Mechanical Jam; Positioning Problem

  IT WAS REPORTED THAT THE LOCKING MECHANISM COULD NOT BE TURNED TO FINAL POSITION DURING THE PROCEDURE. THE PLATE HAD TO BE REMOVED AND REPLACED WITH NEW ONE WITH RESCUE SCREWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5439567 ↗