AVS ARIA 48753212Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252311478), received between Jun 19, 2018 and Jun 19, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2018Labelling, Instructions for Use or Training Problem; Malposition of Device; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT WHILE IN THE OR, A CAGE WAS LOADED ONTO THE INSERTER. IT WAS NOTICED BY THE SURGEON THAT THE ANTERIOR / POSTERIOR MARKERS WERE ON THE WRONG/OPPOSITE SIDES OF THE CAGE. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7615996 ↗
• MalfunctionJun 19, 2018Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT WHILE IN THE OR, A CAGE WAS LOADED ONTO THE INSERTER. IT WAS NOTICED BY THE SURGEON THAT THE ANTERIOR / POSTERIOR MARKERS WERE ON THE WRONG/OPPOSITE SIDES OF THE CAGE. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7615743 ↗