AVIATOR 48811230Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613252152194), received between Apr 13, 2017 and Apr 14, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionApr 14, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY SURGEON THAT AVIATOR TWO LEVEL PLATE WAS 'UNABLE TO FULLY SEAT SCREW PAST SPRING BAR MECHANISM OR ABLE TO FINAL LOCK SECONDARY MECHANISM'. PLATE WAS REMOVED AND A NEW PLATE WAS USED TO COMPLETE THE PROCEDURE WITH 5 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667565 ↗
• MalfunctionJan 21, 2019Fracture; Material Fragmentation; Detachment of Device or Device Component; Device Fell; Fracture

  DURING A TYPICAL ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGERY, THE CERVICAL 2 LEVEL PLATE'S TOP LEFT SIDE LOCKING MECHANISM POPPED OFF AND FELL INTO THE SURGERY AREA. ALL BROKEN FRAGMENTS WERE REMOVED USING A PAIR OF BAYONETTED PICKUPS. THE SURGEON REMOVED PLATE AND REPLACE WITH A NEW PLATE. A SURGICAL DELAY OF 30 MIN WAS REPORTED. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 8265189 ↗
• MalfunctionJul 17, 2017Material Deformation; Material Integrity Problem; Device Dislodged or Dislocated; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT AFTER THE SURGEON PERFORMED A TWO LEVEL ACDF ON A PATIENT HE HAPPEN TO TOUCH THE PLATE PRIOR TO CLOSING THE INCISION AND REALIZED THERE WAS SOMETHING SHARP PROTRUDING. HE THEN NOTICED THAT THE LOCKING SPRING RING HAD POPPED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6720066 ↗
• InjuryApr 13, 2017Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device

  IT WAS REPORTED THAT; PLATE 2 MOST CEPHALAD SCREWS BACKED OUT FOLLOWING NON COMPLIANCE.

  Patient problems: Injury; No Code Available

  MAUDE report 6490355 ↗
• MalfunctionApr 13, 2017Device Operates Differently Than Expected; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT; A CLOSING BAR/WING ON A 2 LEVEL PLATE DID NOT MOVE FORWARD PROPERLY WHEN THE LOCKING NUT WAS FINAL TIGHTENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6490349 ↗