AVIATOR 48814014Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252152507), received between Apr 29, 2019 and May 21, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2019Unintended Movement; Break; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT THE INFERIOR SCREW WAS BACKING OUT AND CAUSED PATIENT DYSPHAGIA; DURING THE REVISION SURGERY, UPON REMOVAL OF THE SCREW, THE SURGEON NOTED THE LOCKING WING OF THE PLATE HAD BROKEN INTO SEVERAL PIECES. ALL PIECES WERE REMOVED FROM THE FIELD.

  Patient problems: Injury

  MAUDE report 8629254 ↗
• MalfunctionApr 30, 2019Failure to Advance; Mechanical Jam; Mechanical Jam

  PHYSICIAN REPORTED THAT, WHILST IMPLANTING A CERVICAL PLATE, TWO OF THE SELF-TAPPING SCREWS, ¿WOULD NOT PASS THE LOCKING MECHANISM.¿ ALL OTHER SCREWS IMPLANTED IN THE ADJACENT LEVELS WERE PLACED WITHOUT ISSUE. THE PHYSICIAN, ¿FELT IT WOULD JEOPARDIZE THE INTEGRITY OF THE CONSTRUCT TO REMOVE AND REPLACE ALL THE SCREWS AND PLACE A NEW PLATE,¿ AND SO OPTED TO COMPLETE SURGERY WITHOUT THE TWO AFOREMENTIONED SCREWS. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE PRODUCT LABELLING INDICATES THAT, ¿THE INSERTION OF THE IMPLANTS MUST BE CARRIED OUT USING INSTRUMENTS DESIGNED AND PROVIDED FOR THIS PURPOSE AND IN ACCORDANCE WITH THE SPECIFIC IMPLANTATION INSTRUCTIONS FOR EACH IMPLANT.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8566533 ↗
• MalfunctionApr 29, 2019Failure to Advance; Mechanical Jam; Mechanical Jam

  PHYSICIAN REPORTED THAT, WHILST IMPLANTING A CERVICAL PLATE, TWO OF THE SELF-TAPPING SCREWS, ¿WOULD NOT PASS THE LOCKING MECHANISM.¿ ALL OTHER SCREWS IMPLANTED IN THE ADJACENT LEVELS WERE PLACED WITHOUT ISSUE. THE PHYSICIAN, ¿FELT IT WOULD JEOPARDIZE THE INTEGRITY OF THE CONSTRUCT TO REMOVE AND REPLACE ALL THE SCREWS AND PLACE A NEW PLATE,¿ AND SO OPTED TO COMPLETE SURGERY WITHOUT THE TWO AFOREMENTIONED SCREWS. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE PRODUCT LABELLING INDICATES THAT, ¿THE INSERTION OF THE IMPLANTS MUST BE CARRIED OUT USING INSTRUMENTS DESIGNED AND PROVIDED FOR THIS PURPOSE AND IN ACCORDANCE WITH THE SPECIFIC IMPLANTATION INSTRUCTIONS FOR EACH IMPLANT.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8563266 ↗