ES2 SPINAL SYSTEM 48280233Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327266450), received between Aug 2, 2017 and Apr 7, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 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.

• MalfunctionApr 7, 2022Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN ES2 K-WIRE FRACTURED DURING SURGERY AND WAS LEFT IN THE PATIENT'S BONE. 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 14042820 ↗
• MalfunctionAug 2, 2017Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; K-WIRE BROKE 3 TIMES WHILE TRYING TO BE REMOVED AS SCREW WAS BEING INSERTED. SURGEON USES A KOCHER IF WIRE SEEMS TO BE STUCK, WHILE GRABBING THE WIRE AND TWISTING THE WIRE IT SNAPPED. ADDITIONAL INFORMATION NOTED; ALL FRAGMENTS WERE RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6760062 ↗