Elite Expandable Interbody Fusion Device 10-10-74-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M7405410008), received between May 15, 2017 and May 15, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2017Break; Break

  IT WAS REPORTED THAT FOLLOWING PLACEMENT OF THE ELITE EXPANDABLE DEVICE IN THE INTERVERTEBRAL DISC SPACE, THE PHYSICIAN USED THE ELITE TORQUE LIMITING HANDLE WITH THE ELITE DRIVER TO EXPAND THE DEVICE AND REPORTED HEARING A CLICK SIGNALING THAT THE TORQUE LIMIT HAD BEEN REACHED. THE PHYSICIAN REMOVED THE TORQUE LIMITING HANDLE FROM THE ELITE DRIVER AND PLACED ANOTHER HANDLE ON THE ELITE DRIVER AND CONTRIBUTED TO EXPAND THE IMPLANT. AFTER SEVERAL ATTEMPTS, THE DRIVER SHAFT ROTATED WITH NO FORCE. FLUOROSCOPIC IMAGING OF THE ELITE IMPLANT REVEALED THAT THE EXPANSION BOLT HAD BROKEN. THE PHYSICIAN WAS ABLE TO REMOVE THE PROXIMAL END OF THE EXPANSION BOLT, HOWEVER, THE DISTAL END REMAINED ENGAGED IN THE NOSE OF THE IMPLANT. THE PHYSICIAN LEFT THE ELITE IMPLANT IN PLACE TO COMPLETE THE SURGICAL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6567705 ↗