AVIATOR 48844016Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613252254713), received between Oct 17, 2016 and Apr 19, 2022 — classified as 3 injuries, 3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2022Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE HEADS OF TWO AVIATOR FIXED SELF-DRILLING SCREWS FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141194 ↗
• InjuryJun 25, 2019Migration; Fracture; Device Dislodged or Dislocated; Migration

  PHYSICIAN REPORTED THAT THE SELF-TAPPING SCREW APPEARED TO HAVE BACKED OUT VIA POST OP IMAGES. DURING EXPLORATORY REVISION SURGERY, IT WAS NOTED THAT THE LOCKING WING OF THE PLATE ON THE SAME LEVEL AS THE BACKED-OUT SCREW, FRACTURED. THE BACKED-OUT SCREW WAS ALSO NOTED TO HAVE FRACTURED. THE PHYSICIAN CONFIRMED ALL THE BROKEN PIECES WERE RETRIEVED. THE PATIENTS WOUND WAS INSPECTED WITH BLUE DIE BY AN ENT SURGEON WHO CONFIRMED THERE WERE NO HOLES IN THE ESOPHAGUS. RETRIEVAL OF THE BROKEN PIECES WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES. THE LOCKING WING WOULD HAVE BEEN FORCED FROM ITS POSITION AND EITHER DEFORMED OR FRACTURED AS THE SCREW BACKED-OUT. THIS RECORD REPRESENTS THE BACKED-OUT SCREW.

  Patient problems: Injury

  MAUDE report 8732909 ↗
• InjuryApr 10, 2019Malposition of Device; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO SCREW PULL OUT POST-OPERATIVELY.

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

  MAUDE report 8501421 ↗
• InjuryOct 28, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE PLATE SPRING BAR POPPED OFF INSIDE PATIENT POST OP. PATIENT UNDERWENT REVISION TO REMOVE THE PLATE AND PUT A NEW ONE ON WITH RESCUE SCREWS.

  Patient problems: Injury

  MAUDE report 8011565 ↗
• 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 7483033 ↗
• MalfunctionOct 17, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem; Positioning Problem

  IT WAS REPORTED THAT DURING SURGERY, IMPLANTING A PLATE, THE SURGEON USED AN AWL TO PREPARE THE SCREW HOLE. WHEN INSERTING THE FIXED SELF DRILLING SCREW THE SURGEON HAD TO REPOSITION THE SCREW. WHEN REDIRECTING THE SCREW THE TRAJECTORY (TABS ON THE OUTSIDE OF THE FEMALE HEX) ONE OF THE TABS BROKE OFF. THE BROKEN PIECE WAS RETRIEVED AND THE SAME SIZED SCREW USED TO COMPLETE THE SURGERY. NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6034771 ↗