AVIATOR 48811228Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613252152187), received between Mar 24, 2016 and Mar 14, 2019 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2019Fracture; Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE METAL LOCKING RING WAS FRACTURED. A REVISION SURGERY WAS PERFORMED AND METAL LOCKING RING WAS REMOVED.

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

  MAUDE report 8420209 ↗
• InjuryNov 28, 2018Fracture; Fracture; Device Dislodged or Dislocated

  THE BOTTOM SCREWS BACKED OUT AND THE LOCKING MECHANISM WAS PUSHED OUT AND SNAPPED ON THE ANTERIOR CERVICAL PLATE. THE ORIGINAL SURGERY WAS APPROXIMATELY 2 YEARS AGO AND THE PATIENT CALLED THE DOCTOR COMPLAINING OF NECK PAIN. REVISION SURGERY OCCURRED.

  Patient problems: Injury; Pain

  MAUDE report 8109704 ↗
• MalfunctionJul 13, 2018Break; Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A 2 LEVEL PLATE LOCKING MECHANISM BROKE PARTIALLY DURING INSERTION OF THE SCREW. THE PLATE REMAINS IN THE PATIENT BUT THE SURGEON NOTICED THAT THE LOCKING MECHANISM SEEMED BENT OVER THE TOP OF THE SCREW. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7687747 ↗
• MalfunctionJun 13, 2018Bent; Break; Fracture; Fracture

  IT WAS REPORTED THAT THE LOCKING BAR ON CERVICAL PLATE BENT AND BROKE AS SCREW WAS GOING IN. THE GOLD LOCK SCREW WAS ORIENTATED IN THE UNLOCK POSITION BUT THE GREY BAR/WING DID NOT SPRING OUT OF THE WAY. THE SURGEON REMOVED THE SCREW, LEAVING ONE SCREW AT THAT LEVEL. THERE HAVE BEEN NO ADVERSE CONSEQUENCES TO THE PATIENT.

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

  MAUDE report 7598012 ↗
• InjuryMar 18, 2018Fracture; Break; Fracture; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT REQUIRED A REVISION SURGERY. THE LOCKING TAB ON THE PLATE WAS BROKEN UPON GOING INTO SURGERY AFTER THE SURGEON NOTICED THE SCREWS AT C7 WERE BACKING OUT OF THE PLATE.

  Patient problems: Injury

  MAUDE report 7347920 ↗
• MalfunctionOct 5, 2016Material Deformation; Material Integrity Problem; Break; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT; TWO 28MM ANTERIOR CERVICAL PLATES HAD THE LOCKING MECHANISM BRAKE DURING SCREW INSERTION. THE THIRD 28MM PLATE WAS INSERTED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5999833 ↗
• MalfunctionOct 5, 2016Material Deformation; Material Integrity Problem; Break; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT; TWO 28MM ANTERIOR CERVICAL PLATES HAD THE LOCKING MECHANISM BRAKE DURING SCREW INSERTION. THE THIRD 28MM PLATE WAS INSERTED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5999336 ↗
• MalfunctionMar 24, 2016Bent; Fracture

  IT WAS REPORTED THAT; THE CUSTOMER REPORTED THAT WHEN BENDING THE PLATE WITH PLATE BENDERS, THE PLATE FRACTURED. THE PLATE WAS BENT IN ONE DIRECTION, AS THE PLATE WAS BENT BACK THE OPPOSITE WAY IT FRACTURED JUST BELOW THE SPRING BAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5524142 ↗