AVIATOR 48811114Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613252152118), received between Nov 22, 2016 and Apr 29, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE LOCKING MECHANISM OF AN AVIATOR ONE LEVEL PLATE DETACHED POST-OPERATIVELY CAUSING AN AVIATOR SCREW TO MIGRATE. THE DEVICES REMAIN IMPLANTED, REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME. THIS REPORT CAPTURES THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255468 ↗
• MalfunctionMar 5, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT LOCKING RING ON PLATE BROKE OFF. ALL BROKEN FRAGMENTS WERE RETRIEVED. A SURGICAL DELAY OF A MINUTE OR TWO WAS REPORTED. THE PLATE WAS LEFT IN THE PATIENT. NO ADVERSE CONSEQUENCES TO THE PATIENT WAS REPORTED AT THIS TIME. THIS WILL BE REPORTED DUE TO THE POSSIBILITY OF SCREW PULL OUT IN THE FUTURE.

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

  MAUDE report 8392080 ↗
• MalfunctionSep 18, 2018Detachment of Device or Device Component; Material Deformation; Material Deformation

  SPRING BAR POPPED OFF PLATE WHEN ADVANCING SCREW ON ADJACENT SIDE OF THE PLATE. THE 10 MINUTE DELAY TO REPLACE PLATE AND SCREWS. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7884623 ↗
• MalfunctionJun 6, 2018Fracture; Mechanical Problem; Fracture

  IT IS REPORTED THAT UPON ATTEMPTING TO INSERT SCREW INTO THE PLATE THE LOCKING MECHANISM FAILED AND NO LONGER WOULD LOCK. SURGEON JUST USED ANOTHER PLATE OF THE SAME SIZE. NO ADVERSE CONSEQUENCES AND NO SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7572707 ↗
• InjuryJan 10, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT; AVIATOR PLATE WAS REMOVED DUE TO BROKEN LOCKING MECHANISM.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7180284 ↗
• MalfunctionJul 17, 2017Fracture; Break; Fracture

  IT WAS REPORTED THAT TH LOCKING MECHANISM BROKE.

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

  MAUDE report 6720065 ↗
• MalfunctionApr 18, 2017Mechanical Problem; Material Deformation; Material Protrusion/Extrusion; Material Deformation

  IT WAS REPORTED THAT 14MM PLATE LOCKING MECHANISM FELL OFF THE TRACK ON LOCKING AND WAS PROTRUDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6501563 ↗
• MalfunctionNov 22, 2016Material Deformation

  IT WAS REPORTED THAT THEY WERE DOING AN ACDF WITH PLATING AND THAT WHEN PLACING THE SCREWS INTO THE PLATE, THE SILVER LOCKING WING ON THE PLATE APPEARED TO DEFORM. THE SURGEON DID NOT WANT TO CONTINUE USING THIS PARTICULAR PLATE, SO SWAPPED IT FOR A NEW ONE OF THE SAME SIZE AND MAKE. UPDATE: THE SURGEON FURTHER REPORTED THAT HE PUT THE SCREW IN AND THEN WANTED TO REPOSITION IT. WHEN HE TRIED TO REMOVE THE SCREW, IT HAD GONE PAST THE LOCKING MECHANISM AND BROKE AS IT WAS TAKEN OUT. HE SAID HE BROKE THE WING ON THE PLATE. THE SCREW DID NOT BREAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6120193 ↗