ES2 SPINAL SYSTEM 482804750Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327002249), received between Jan 24, 2018 and Sep 5, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982088 ↗
• MalfunctionJul 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A COMPANY REPRESENTATIVE REPORTED THAT THE TULIP OF AN ES2 INTEGRATED BLADE SCREW DISENGAGED FROM THE SCREW INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 15 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22672369 ↗
• MalfunctionJul 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A COMPANY REPRESENTATIVE REPORTED THAT THE TULIP OF AN ES2 INTEGRATED BLADE SCREW DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494561 ↗
• InjuryOct 27, 2020Migration; Migration

  IT WAS REPORTED THAT TWO ES2 INTEGRATED BLADE SCREWS AT S1 MIGRATED APPROXIMATELY TWO YEARS AND 9 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED. THIS REPORT REPRESENTS THE FIRST OF THE TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10742674 ↗
• InjuryOct 27, 2020Migration; Migration

  IT WAS REPORTED THAT TWO ES2 INTEGRATED BLADE SCREWS AT S1 MIGRATED APPROXIMATELY TWO YEARS AND 9 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED. THIS REPORT REPRESENTS THE SECOND OF THE TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10742652 ↗
• InjuryJan 24, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT; THE SCREW BROKE [HEAD DETACHED FROM SHANK]. IT WAS REPORTED THAT THE UNIT HAD BEEN ORIGINALLY IMPLANTED A COUPLE WEEKS PRIOR. IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY TO REMOVE BROKEN HARDWARE.

  Patient problems: Failure of Implant; Injury; No Code Available

  MAUDE report 7215255 ↗