ES2 SPINAL SYSTEM 482804760Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327002393), received between Sep 3, 2020 and Dec 19, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853773 ↗
• InjurySep 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THREE ES2 INTEGRATED BLADE SCREW TULIPS AT L4 LEFT/RIGHT AND L3 LEFT DISENGAGED POST-OPERATIVELY. THE PATIENT WAS IMPLANTED WITH ES2 SCREWS ON (B)(6) 2020. THE PATIENT WAS REVISED ON (B)(6) 2020, WHERE THE SCREWS WERE EXPLANTED AND REPLACED. THIS REPORT CAPTURES THE L4 LEFT SIDE SCREW.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10489626 ↗
• InjurySep 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THREE ES2 INTEGRATED BLADE SCREW TULIPS AT L4 LEFT/RIGHT AND L3 LEFT DISENGAGED POST-OPERATIVELY. THE PATIENT WAS IMPLANTED WITH ES2 SCREWS ON (B)(6) 2020. THE PATIENT WAS THEN REVISED ON (B)(6) 2020, WHERE THE SCREWS WERE EXPLANTED AND REPLACED. THIS REPORT CAPTURES THE L3 LEFT SIDE SCREW.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10489619 ↗
• InjurySep 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THREE ES2 INTEGRATED BLADE SCREW TULIPS AT L4 LEFT/RIGHT AND L3 LEFT DISENGAGED POST-OPERATIVELY. THE PATIENT WAS IMPLANTED WITH ES2 SCREWS ON (B)(6) 2020. THE PATIENT WAS THEN REVISED ON (B)(6) 2020, WHERE THE SCREWS EXPLANTED AND REPLACED. THIS REPORT CAPTURES THE L4 RIGHT SIDE SCREW.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10489600 ↗