ES2 SPINAL SYSTEM 482802770Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327002058), received between Apr 5, 2017 and Oct 29, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A CUSTOMER REPORTED THAT THE TULIP OF AN ES2 INTEGRATED BLADE SCREW DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418564 ↗
• MalfunctionApr 5, 2017Detachment Of Device Component; Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  IT WAS REPORTED THAT; THIS EVENT OCCURRED AT THE FIXATION OF THE L4/5 AND THE ILIAC BONE OF THE PELVIC FRACTURE. WHEN THE FINAL TIGHTENING OF THE BLOCKER AT RIGHT L4 SCREW, THE SURGEON CONFIRMED THAT THE SCREW HEAD CAME OFF FROM THE SCREW SHAFT . AFTER THAT, THE SURGEON PULLED OUT THE ROD AND CONFIRMED THAT THE SCREW OF THE L5 AND ILIAC BONE WHICH WAS ALREADY IMPLANTED. THE TWO SCREW HEADS WERE CAME OFF FROM THE SCREW SHAFT TOO. THEREFORE, THE THREE SCREWS WERE EXCHANGED THE NEW OTHER SIZE SCREWS AND THE OPERATION WAS SUCCEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6460587 ↗