ES2 SPINAL SYSTEM 482804745Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327002232), received between Sep 1, 2017 and Nov 7, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 18, 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.

• MalfunctionNov 7, 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 15 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23499001 ↗
• InjuryMar 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE TULIP OF AN ES2 INTEGRATED BLADE SCREW DISENGAGED FROM THE SCREW SHANK INTRA-OPERATIVELY AND THAT THE SCREW SHANK REMAINS IMPLANTED IN THE PATIENT. THE SURGERY WAS COMPLETED WITH A 90 MINUTE SURGICAL DELAY. IT WAS FURTHER REPORTED THAT THE PATIENT'S HOSPITALIZATION WAS EXTENDED BY THREE DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21545385 ↗
• MalfunctionMay 2, 2023Material Separation; Material Separation

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT IMPLANTED WITH ES2 PEDICLE SCREWS FOR A ONE LEVEL LUMBAR FUSION PRESENTED WITH A SURGICAL INFECTION APPROXIMATELY ONE-MONTH POST-OPERATIVELY. DURING REMOVAL OF THE IMPLANTED HARDWARE IT WAS DISCOVERED THAT TULIP OF AN ES2 LONG BLADE CANNULATED SCREW HAD DISENGAGED. THE TULIP OF THE SCREW WAS EXPLANTED BUT THE SHAFT OF THE SCREW WAS UNABLE TO BE REMOVED AND WAS LEFT IN THE PEDICLE.

  Patient problems: Unspecified Infection

  MAUDE report 16857579 ↗
• MalfunctionSep 1, 2017Fracture; Break; Fracture

  IT WAS REPORTED THAT; WHEN REDUCTION WITH THE REDUCTION THREAD AT THE LUMBAR SPONDYLOLISTHESIS AT L4 PART, THE BLADE SCREW WAS BROKEN. ALTHOUGH THE SURGEON WAS TRIED TO USE THE RECOVERY SYSTEM, IT WAS NOT SE WITH SCREW. THEREFORE, THE SCREW WAS CHANGED THE NEW ONE AND THE OPERATION WAS SUCCEEDED. THE BLADE WAS NOT RESISTED THE FORCE OF THE REDUCTION, BECAUSE THE BONE QUALITY WAS GOOD AND THE SCREW FIXATION WAS GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6838768 ↗