ES2 SPINAL SYSTEM 482802650Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327001952), received between Sep 16, 2016 and Jun 5, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AFTER IMPLANTATION DURING A PLANNED REVISION SURGERY TO ADDRESS LUMBAR STENOSIS OF L4/5, IT WAS OBSERVED THAT AN ES2 SHORT BLADE CANNULATED SCREW AT RIGHT S1 HAD FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17065319 ↗
• InjuryAug 14, 2019Fracture; Appropriate Device Problem Term/Code Not Available; Fracture

  POST-OPERATIVE X-RAY INDICATED THAT A PIECE OF THE REMOVABLE BLADE OF AN ES2 INTEGRATED BLADE SCREW REMAINED IN THE PATIENT. THE PATIENT WAS REVISED UNDER LOCAL ANESTHESIA ON (B)(6) 2019 TO EXTRACT THE PORTION OF THE REMOVABLE BLADE.

  Patient problems: Injury

  MAUDE report 8893562 ↗
• InjuryMay 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 OSING SCREWS.

  Patient problems: Injury; No Code Available

  MAUDE report 6578640 ↗
• 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. ON (B)(6) 2017 LOOSED FOUR SCREWS AND DISLODGED THE GAGE. ON (B)(6) 2017, IT WAS REMOVED TO NEW SCREW(OTHER COMPANY) FROM FOUR OSING SCREWS.

  Patient problems: Injury; No Code Available

  MAUDE report 6578635 ↗
• MalfunctionSep 19, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT; ON (B)(6 )2016, ES2 SURGERY FOR L2/3 BURST FRACTURE WAS PERFORMED. T12-L5 WERE FIXED, L2 WERE SKIPPED. AFTER THE SURGERY, THE BREAKAGE OF BOTH SIDE L5 SCREW WAS FOUND. ALL THE IMPLANT WERE EXTRACTED ON (B)(6) 2016 BECAUSE THE FRACTURE HAS HEALED. THE TIPS OF THE BROKEN SCREWS WERE REMAINED TO THE PATIENT. UPDATE: PATIENT WAS FUSED.

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

  MAUDE report 5959444 ↗
• MalfunctionSep 16, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT; ON (B)(6) 2016, ES2 SURGERY FOR L2/3 BURST FRACTURE WAS PERFORMED. T12-L5 WERE FIXED, L2 WERE SKIPPED. AFTER THE SURGERY, THE BREAKAGE OF BOTH SIDE L5 SCREW WAS FOUND. ALL THE IMPLANT WERE EXTRACTED ON (B)(6) 2016 BECAUSE THE FRACTURE HAS HEALED. THE TIPS OF THE BROKEN SCREWS WERE REMAINED TO THE PATIENT. UPDATE: PATIENT WAS FUSED.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 5957731 ↗