AVIATOR 48824016Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613252152613), received between Apr 10, 2019 and Jun 23, 2020 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2020Migration; Migration

  IT WAS REPORTED THAT AN AVIATOR ASSY 3-LEVEL PLATE SECURING MECHANISM FRACTURED AND 3 AVIATOR SCREWS MIGRATED POST-OPERATIVELY THREE WEEKS AFTER IMPLANTATION. THE PATIENT HAS UNDERGONE REVISION SURGERY AND THE SCREWS HAVE BEEN EXPLANTED. THE PLATE REMAINS IMPLANTED. THIS REPORT WILL CAPTURE THE THIRD OF THREE SCREWS.

  Patient problems: Injury

  MAUDE report 10186781 ↗
• InjuryJun 23, 2020Migration; Migration

  IT WAS REPORTED THAT AN AVIATOR ASSY 3-LEVEL PLATE SECURING MECHANISM FRACTURED AND 3 AVIATOR SCREWS MIGRATED POST-OPERATIVELY THREE WEEKS AFTER IMPLANTATION. THE PATIENT HAS UNDERGONE REVISION SURGERY AND THE SCREWS HAVE BEEN EXPLANTED. THE PLATE REMAINS IMPLANTED. THIS REPORT WILL CAPTURE THE FIRST OF THREE SCREWS.

  Patient problems: Injury

  MAUDE report 10186773 ↗
• InjuryJun 12, 2019Device Dislodged or Dislocated

  PATIENT UNDERWENT REVISION SURGERY TO REMOVE TWO SCREWS WHICH BACKED OUT POST-OPERATIVELY. ADDITIONAL INFORMATION RECEIVED FROM PATIENT INDICATES THEY EXPERIENCED DISCOMFORT SWALLOWING AND, ¿PRESSURE ON THE BACK OF MY ESOPHAGUS,¿ PRIOR TO REVISION SURGERY. THIS REPORT CAPTURES THE FIRST OF THE TWO SCREWS.

  Patient problems: Discomfort; Injury

  MAUDE report 8692029 ↗
• InjuryJun 12, 2019Device Dislodged or Dislocated

  PATIENT UNDERWENT REVISION SURGERY TO REMOVE TWO SCREWS WHICH BACKED OUT POST-OPERATIVELY. THIS REPORT CAPTURES THE SECOND OF THE TWO SCREWS."

  Patient problems: Discomfort; Injury

  MAUDE report 8692028 ↗
• MalfunctionApr 16, 2019Device Slipped; Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR 1 LEVEL ACDF REVISION PROCEDURE DUE TO DEGENERATIVE DISC DISEASE. RIGHT BEFORE THE PROCEDURE, X-RAY REVIEW REVEALED THAT SCREW FROM PLATE WAS BACKING OUT FROM PREVIOUS SURGERY. THEREFORE, THE SURGEON REPLACED THE PLATE AND SCREWS DURING REVISION SURGERY AND THIS RESULTED IN 30 MINUTES SURGICAL DELAY.

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

  MAUDE report 8518411 ↗
• InjuryApr 10, 2019Device Dislodged or Dislocated; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Migration; Unintended Movement; Migration

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

  Patient problems: Discomfort; Failure of Implant; Feeding Problem; Laceration(s) of Esophagus

  MAUDE report 8501409 ↗
• InjuryApr 10, 2019Device Slipped; Unintended Movement; Migration; Unintended Movement; Migration

  IT WAS REPORTED THAT THE PLATE SECURING MECHANISM WAS FOUND DEFORMED/FRACTURED AT C7 LEVEL. THE REVISION SURGERY WAS EXTENDED AN ADDITIONAL HOUR DUE TO THE NEED TO CLOSE THE MEMBRANE SURROUNDING THE ESOPHAGUS. THE PATIENT WAS REQUIRED TO HAVE A FEEDING TUBE FOR A PERIOD OF TIME; DURATION NOT REPORTED. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT BRAND CERVICAL PLATE. THERE WERE NO COMPLICATIONS DURING THE INITIAL SURGERY. IT WAS CONFIRMED THAT THE SCREWS WERE POSITIONED BELOW THE SPRING BAR AND THE PLATE¿S LOCKING MECHANISM WAS IN THE LOCKED POSITION. SCREW HOLES WERE PREPARED WITH VARIABLE AWL AND WERE IMPLANTED AT A DIFFICULT ANGLE. PATIENT WAS REPORTED TO HAVE GOOD BONE PURCHASE, DID NOT DO ANY STRENUOUS ACTIVITY, AND DID NOT EXPERIENCE A FALL.

  Patient problems: Discomfort; Feeding Problem; Laceration(s) of Esophagus; No Code Available

  MAUDE report 8499124 ↗