AVIATOR 48770410Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327273038), received between Mar 9, 2016 and Jun 10, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT AN AVIATOR TEMPORARY FIXATION PIN SNAPPED IN HALF DURING INSERTION INTO THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14658355 ↗
• MalfunctionSep 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF AN AVIATOR TEMPORARY FIXATION PIN FRACTURED INTRA-OPERATIVELY, DURING INSERTION AT C6. THE FRACTURED COMPONENT WAS LEFT IN THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450162 ↗
• MalfunctionFeb 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING INSERTION, THE TIP OF AN AVIATOR TEMPORARY FIXATION PIN BROKE OFF INTO THE VERTEBRAL BODY INTRA-OPERATIVELY. THE TIP COULD NOT BE RETRIEVED BECAUSE IT BROKE OFF BENEATH THE SURFACE OF THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11373796 ↗
• MalfunctionApr 3, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF AN AVIATOR TEMPORARY FIXATION PIN TIP FRACTURED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A LESS THAN 5 MINUTE SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9921143 ↗
• MalfunctionAug 29, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE TEMPORARY FIXATION PIN TIP BROKE OFF DURING INSERTION. SURGEON WAS ABLE TO GET REMOVE BROKEN TIP. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7831421 ↗
• MalfunctionMay 3, 2018Fracture; Break; Fracture

  IT IS REPORTED THAT FIXATION PIN FOR THE PLATE BROKE AT THE DISTAL END DURING SCREWING IN. THE DISTAL END STAYED INTO THE PATIENT. THE ROUND HEAD PART OF THE SCREW BROKE APART. NEW SCREW WAS IMPLANTED. SURGICAL DELAY OF 30MIN IS REPORTED. NO ADVERSE CONSEQUENCES IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7483034 ↗
• MalfunctionMay 26, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; DOCTOR DOING OCCIPITAL FUSION WANTED A TEMPORARY FIXATION PIN. HE ASKED TO GET A SET AND USED THE PIN TO SECURE PLATE ONTO THE OCCIPUT. UPDATE 5/3/2017: THE FIXATION PIN BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6595239 ↗
• MalfunctionJan 20, 2017Break; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT REMOVING FIXATION PIN FROM PATIENT, THE PIN SNAPPED OFF

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6267901 ↗
• MalfunctionMar 9, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT WHILE COMPLETING A C6-7 ACDF, UPON REMOVAL OF THE TEMPORARY FIXATION PIN, THE PIN SNAPPED IN HALF, LEAVING THE DISTAL PORTION (APPROX 6-8MM) IN-SITU ON THE RIGHT SIDE OF C6.

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

  MAUDE report 5489942 ↗