ES2 SPINAL SYSTEM 482807080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327001525), received between Dec 20, 2016 and Dec 20, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 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.

• MalfunctionDec 20, 2016Fracture; Material Integrity Problem; Fracture; Difficult to Remove; Material Separation; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2015 4 SCREWS WERE IMPLANTED FOR L1 RIGHT WITHOUT PROBLEM. ON (B)(6) 2016 ATTEMPTED TO REMOVE AFTER FUSED BONES OF THE SPINE BY PLAN, BUT A SCREW HAD BEEN SEPARATED, SO COULDN'T REMOVE IT OUT OF PATIENT BODY. OTHER 3 SCREWS HAVE BEEN COMPLETED TO REMOVE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6190944 ↗