AVIATOR 48834018Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252254621), received between Sep 14, 2018 and Sep 14, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2018Mechanical Problem; Detachment of Device or Device Component; Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A 22 MM PLATE WAS TO BE ATTACHED TO THE CERVICAL SPINE, USING 4MM X 18MM SELF-TAPPING SCREWS, PRE-DRILLED WITH 16MM PRE-DRILLS. 3 SCREWS COULD BE VERY TIGHTLY INSERTED WHILE 1 SCREW WAS OVER-TIGHTENED AND COULD NOT BE FIXED. THE PLATE'S LOCKING MECHANISM COULD NOT SLIDE OVER THE SCREW HEADS. WHEN UNSCREWING, PARTS OF THE SCREW THREAD WERE SHEARED OFF IN SITU. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW 20 MM PLATE,16 MM SCREWS AND NEW PLACEMENT FOR THE PLATE ON THE CERVICAL VERTEBRA. THERE WAS A REPORTED 60 MINUTES DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7876476 ↗
• MalfunctionSep 14, 2018Break; Mechanical Problem; Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A 22 MM PLATE WAS TO BE ATTACHED TO THE CERVICAL SPINE, USING 4MM X 18MM SELF-TAPPING SCREWS, PRE-DRILLED WITH 16MM PRE-DRILLS. THREE SCREWS COULD BE VERY TIGHTLY INSERTED WHILE 1 SCREW WAS OVER-TIGHTENED AND COULD NOT BE FIXED. THE PLATE'S LOCKING MECHANISM COULD NOT SLIDE OVER THE SCREW HEADS. WHEN UNSCREWING, PARTS OF THE SCREW THREAD WERE SHEARED OFF IN SITU. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW 20 MM PLATE,16 MM SCREWS AND NEW PLACEMENT FOR THE PLATE ON THE CERVICAL VERTEBRA. THERE WAS A REPORTED 60 MINUTES DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7876470 ↗