AVS 48350952Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327267990), received between Nov 15, 2016 and Apr 24, 2017 — classified as 3 malfunctions.

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

• MalfunctionApr 24, 2017Bent; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT; THE INNER SHAFT OF THE INSERTER HAVE BEEN BENT WHEN IMPLANTING INTERBODY. THE BENT PORTION IS THE THREADED, DISTAL TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6517275 ↗
• MalfunctionNov 15, 2016Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT; DURING SURGERY, A SURGEON FOUND THE WEAR OF THE INSERTER TIP. THE SURGEON MENTIONED THAT THE WEARING TIP IS LIKELY TO DAMAGE THE DURA MATER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6104652 ↗
• MalfunctionNov 15, 2016Material Deformation; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT; DURING SURGERY, A SURGEON FOUND THE WEAR OF THE INSERTER TIP. THE SURGEON MENTIONED THAT THE WEARING TIP IS LIKELY TO DAMAGE THE DURA MATER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6104554 ↗