AVS ARIA 48750110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252310518), received between Sep 5, 2018 and Sep 5, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT DURING LATERAL CAGE INSERTION, THE CAGE BROKE. ANOTHER CAGE OF THE SAME SIZE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PROCEDURE WAS AT THE L2-L3 LEVEL ANS INSERTION ANGLE WAS NOTED DIFFICULT. ALL BROKEN FRAGMENTS WERE RETRIEVED AND NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7847862 ↗
• MalfunctionSep 5, 2018Fracture; Material Fragmentation; Fracture

  IT WAS REPORTED THAT DURING LATERAL CAGE INSERTION, THE CAGE BROKE. ANOTHER CAGE OF THE SAME SIZE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PROCEDURE WAS AT THE L2-L3 LEVEL ANS INSERTION ANGLE WAS NOTED DIFFICULT. ALL BROKEN FRAGMENTS WERE RETRIEVED AND NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7847792 ↗
• MalfunctionSep 5, 2018Fracture; Material Fragmentation; Fracture

  IT WAS REPORTED THAT DURING LATERAL CAGE INSERTION, THE CAGE BROKE. ANOTHER CAGE OF THE SAME SIZE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PROCEDURE WAS AT THE L2-L3 LEVEL ANS INSERTION ANGLE WAS NOTED DIFFICULT. ALL BROKEN FRAGMENTS WERE RETRIEVED AND NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7847791 ↗