AVIATOR 48811354Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252152316), received between Mar 21, 2016 and Nov 12, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionNov 12, 2019Material Deformation; Material Deformation; Material Twisted/Bent

  PHYSICIAN REPORTED THAT THE LOCKING WING OF AN AVIATOR ASSY THREE LEVEL PLATE SIZE 54 BENT WHEN THE SURGEON REMOVED THE PLATE INTRA-OPERATIVELY.

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

  MAUDE report 9312381 ↗
• 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 8563267 ↗
• MalfunctionMar 21, 2016Break; Fracture; Material Integrity Problem; Bent; Break; Fracture; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE SCREWS WERE INSERTED AND ENGARDED WITH LATE AT ALL LEVELS WITHOUT INCIDENT. UPON FINAL CAM LOCK TIGHTENING IT WAS NOTICED BY THE SURGEON THAT THE SPRING BAR HAD DEFORM UNILATERALLY AT TWO SEPARATE LEVELS. SLING BAR DID NOT TRANSLATE AND WAS BENT / PINCHED UNDER THE SCREW LIP. THIS MADE THE PLATE UNABLE TO LOCK AT ALL LEVELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5514728 ↗