ES2 SPINAL SYSTEM 48280081Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327266313), received between Apr 24, 2018 and Oct 18, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 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.

• MalfunctionOct 18, 2019Device Displays Incorrect Message; Naturally Worn; Naturally Worn

  A PHYSICIAN REPORTED AN, "EASE OF TURNING," AN ES2 TORQUE WRENCH USED DURING THE IMPLANTATION OF A SET SCREW.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9211665 ↗
• MalfunctionApr 24, 2018Material Deformation; Loose or Intermittent Connection; Material Deformation

  IT WAS REPORTED THAT WHEN ATTEMPTING TO FINAL TIGHTEN A 2 LEVEL ROD AND SCREW CONSTRUCT, THE SURGEON WAS UNABLE TO TIGHTEN DOWN THE BLOCKER ENOUGH TO COMPLETELY STOP THE RODS FROM HAVING MICRO MOVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7455679 ↗