AVIATOR 48844014Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252254706), received between Jun 17, 2016 and Aug 20, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A 2 LEVEL ACDF PROCEDURE WHEN THE TOP OF THE SCREW HAD BROKEN AND SOME DEBRIS HAD COME OFF THE SCREW DURING INSERTION. THE SURGEON HAD JUST ENGAGED THE SCREW WITH THE BONE AND DID NOT SCREW IN WHEN HE NOTICED THE SCREWDRIVER MOVE AND THE BREAKAGE APPEARED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7797478 ↗
• MalfunctionJun 8, 2018Fracture; Loose or Intermittent Connection

  IT WAS REPORTED THAT A PATIENT HAD A PRIMARY SURGERY TO THE CERVICAL SPINE (B)(6) 2014. IN 2018 IT WAS CONFIRMED THAT HE HAD NECK KYPHOSING AND SCREW LOOSENING. REVISION ACDF/ CORPECTOMY WAS PERFORMED ON (B)(6) 2018. THE SURGEON REMOVED A PREVIOUSLY IMPLANTED 2 LEVEL AVIATOR PLATE AND SCREWS FROM THE PATIENTS CERVICAL SPINE. UPON REMOVAL OF ONE OF THE SCREWS, THE SCREW HAD FRACTURED IN HALF AND ONLY HALF THE SCREW WAS REMOVED FROM THE PATIENT. WHEN REMOVING ADDITIONAL SCREWS, IT WAS NOTICED THE SPRING BAR LOCKING MECHANISM OF THE PLATE WAS DAMAGED.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 7584653 ↗
• MalfunctionJun 5, 2018Fracture

  IT IS REPORTED THAT DURING A REVISION CASE, THE SURGEON ATTEMPTED TO IMPLANT A 4.0 X 14MM FIXED, SELF- DRILLING SCREW. WHEN INSERTING A NEW SCREW INTO THE NEW PLATE, THE CIRCULAR RING AROUND THE SCREW FRACTURED. THE REVISION SURGERY IS ADDRESSED IN A DIFFERENT RECORD. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED DUE TO SCREW RING FRACTURE. 5 MINUTES DELAY IS REPORTED.

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

  MAUDE report 7571481 ↗
• MalfunctionJun 17, 2016Device Operates Differently Than Expected; Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT; THE SURGEON WAS USING A PLATE. ONE OF THE SCREWS WAS BOTTOMING OUT AND WOULD NOT GO BELOW THE PLATE. TRIED A RESCUE SCREW AND IT DID BETTER. ONE MINUTE DELAY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5732072 ↗