ES2 SPINAL SYSTEM 482802750Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327002027), received between Jan 16, 2017 and Feb 21, 2020 — classified as 4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 21, 2020Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT AN ES2 INTEGRATED BLADE POLYAXIAL SCREW WAS FOUND FRACTURED AT THE TAB AND DISENGAGED INTRA-OPERATIVELY DURING A PLANNED REVISION FOR EXTENSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9742220 ↗
• MalfunctionMay 19, 2017Loose or Intermittent Connection; Mechanical Problem; Migration or Expulsion of Device; Device Dislodged or Dislocated; Mechanical Problem; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2017 IMPLANTED THE PROCEDURE. (B)(6) 2017 LOOSED FOUR SCREWS AND DISLODGED THE GAGE. (B)(6) 2017, IT WAS REMOVED TO NEW SCREW (OTHER COMPANY) FROM FOUR USING SCREWS

  Patient problems: Injury; No Code Available

  MAUDE report 6578639 ↗
• MalfunctionApr 28, 2017Detachment Of Device Component; Mechanical Problem; Connection Problem; Detachment Of Device Component; Mechanical Problem

  IT WAS REPORTED THAT "LUMBALE ARTRODESE L5-S1, SPONDYLOLISTHESES. TOGGLE AFTER FINAL FIXATION S1 SCREW ON THE RIGHT. PREPARING TO DISTRACTION TO GET OPEN NEUROFORAMEN AND TO ACHIEVE REDUCTION OF THE LISTHESIS. TUBES PLACED ON THE SLEEVES. CONNECTED TO EACH OTHER TO MAKE DISTRACTION POSSIBLE. AT THAT TIME, BEFORE THE DISTRACTION, THE TOGGLE SCREW S1 WAS DETECTED ON THE RIGHT. SEVERAL CHECKS WITH X-RAY TO SEE IF THE SCREW WOULD NOT SIT PROPERLY, BUT NOTHING POINTED IN THAT DIRECTION. DISTRACTION CARRIED OUT, AGAIN X-RAY. VISIBLE THAT TULIP WAS NOT CONNECTED TO THE SCREW. DISASSEMBLY, SCREW EXTRACTION. NEW SCREW TAKEN (ONE THAT WAS 5MM LONGER, SAME DIAMETER). NEW ASSEMBLY, DISTRACTION PERFORMED AGAIN AND AFTER CAGE PLACEMENT, BILATERAL COMPRESSION. REDUCTION OF LISTHESIS ALSO PERFORMED."

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6530427 ↗
• MalfunctionJan 16, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT A PRIMARY SURGERY WAS PERFORMED FOR PURULENT SPONDYLITIS ON (B)(6) 2016. THE SYMPTOMS CURED, THE EXTRACTION SURGERY WAS PERFORMED ON (B)(6) 2016. DURING SURGERY, THE SURGEON NOTICED THAT THE S1 LEFT SCREW HAS BROKEN. THE TIP OF THE SCREW COULD NOT BE REMOVED AND WAS REMAINED TO THE PATIENT. AS PER ADDITIONAL INFORMATION, THE EXTRACTION SURGERY WAS NOT DUE TO THE FRACTURED SCREW, FRACTURED SCREW WAS IDENTIFIED DURING THE EXTRACTION SURGERY. THE PATIENT HAD FUSED.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6254584 ↗