ES2 SPINAL SYSTEM 48280090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327006964), received between Feb 20, 2018 and Feb 20, 2018 — 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.

• MalfunctionFeb 20, 2018Difficult to Remove; Sticking

  IT WAS REPORTED THAT AN INSERTER WOULD NOT DISENGAGE FROM ROD. SURGEON DISENGAGED LOCK SCREW AND IT WOULD NOT RELEASE AS IT WAS HUNG UP ON THE HEX. A COBB WAS USED TO PUSH IT OFF AN IT WOULD NOT RELEASE. SURGEON HAD TO TAKE THE ROD BACK OUT AND INCREASE THE INCISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7281700 ↗