ES2 SPINAL SYSTEM 482802745Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613327002010), received between Apr 18, 2016 and Sep 8, 2026 — classified as 11 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Migration

  Patient problems: Insufficient Information

  MAUDE report 50680247 ↗
• InjurySep 8, 2026Migration

  Patient problems: Insufficient Information

  MAUDE report 50680245 ↗
• InjurySep 8, 2026Migration

  Patient problems: Insufficient Information

  MAUDE report 50680242 ↗
• MalfunctionNov 19, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE WEEK POST-OPERATIVELY, IMAGING REVEALED THAT THE TULIP OF AN ES2 INTEGRATED BLADE SCREW HAD DISENGAGED FROM THE SHAFT AT LEFT T11. CURRENTLY THERE IS NO PLAN TO REVISE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725372 ↗
• MalfunctionOct 15, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem

  IT WAS REPORTED THAT THE TAB OF AN ES2 BLADE SCREW WAS DAMAGED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR REPORTED SURGICAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12642115 ↗
• MalfunctionApr 8, 2020Fracture; Fracture

  IT WAS REPORTED THAT AN ES2 INTEGRATED BLADE SCREW TAB FRACTURED DURING DISTRACTION INTRA-OPERATIVELY. THE BLOCKER WAS UNABLE TO BE INSERTED INTO THE SCREW CORRECTLY WITH THE BROKEN BLADE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT SURGICAL DELAY, BY REPLACING THE SCREW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9935854 ↗
• MalfunctionMar 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT AN ES2 INTEGRATED BLADE SCREW TAB FRACTURED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY BY USING PLIERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9865273 ↗
• InjuryJul 25, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP, ONE MONTH AFTER IMPLANTATION, A CT IMAGE CONFIRMED THAT AN ES2 INTEGRATED BLADE SCREW TULIP, SIZE S 7.5MM, DISENGAGED POST-OPERATIVELY. REVISION SURGERY ANTICIPATED BUT NOT YET SCHEDULED. THIS RECORD REPRESENTS 2 OF 2 SCREWS.

  Patient problems: Injury

  MAUDE report 8826712 ↗
• InjuryJul 25, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP, ONE MONTH AFTER IMPLANTATION, A CT IMAGE CONFIRMED THAT AN ES2 INTEGRATED BLADE SCREW TULIP, SIZE S 7.5MM, DISENGAGED POST-OPERATIVELY. REVISION SURGERY ANTICIPATED BUT NOT YET SCHEDULED. THIS RECORD REPRESENTS 1 OF 2 SCREWS.

  Patient problems: Injury

  MAUDE report 8826711 ↗
• InjuryApr 2, 2019Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT GOT PARALYSIS AFTER REVISION SURGERY FOR SCREW HEAD REMOVAL.

  Patient problems: Paralysis

  MAUDE report 8476660 ↗
• InjuryDec 28, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SCREW HEAD CAME OFF POST-OPERATIVELY. PER THE CORRESPONDENCE WITH REP, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 TO REPLACE HARDWARE OF BIGGER SIZE.

  Patient problems: Injury; No Code Available

  MAUDE report 8203241 ↗
• InjuryDec 10, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT SCREW HEAD DETACHED POST-OPERATIVELY. THE PATIENT WAS IN PAIN AND UNDERWENT REVISION SURGERY ON (B)(6) 2018. THIS COMPLAINT WILL BE REPORTED AS SERIOUS INJURY DUE TO MEDICAL INTERVENTION.

  Patient problems: Failure of Implant; Injury; Pain

  MAUDE report 8146638 ↗
• InjuryNov 28, 2018Fracture

  PATIENT EXPERIENCED PAIN SOME TIME AFTER SURGERY. A SCREW WHICH HAD BEEN IMPLANTED HAD FRACTURED. THERE WAS NO ISSUE WITH THE ORIGINAL PROCEDURE, AND THERE HAS NOT BEEN A REVISION SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque; Injury; No Known Impact Or Consequence To Patient; Pain

  MAUDE report 8109693 ↗
• InjuryMar 18, 2018Disconnection; Disconnection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A SCREW WAS ORIGINALLY IMPLANTED ON (B)(6) 2017. REVISION SURGERY WAS PERFORMED DUE TO THE HEAD OF THE SCREW COMING OFF OF THE TULIP HEAD.

  Patient problems: Injury

  MAUDE report 7347918 ↗
• MalfunctionNov 7, 2017Detachment Of Device Component; Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT; FINAL TIGHTENING WAS PERFORMED FOR THE SCREW ON THE RIGHT SIDE OF L 4, AFTER TREATMENT FOR THE L 3, COMPRESSION WAS ADDED BASED ON L 4. AT THAT TIME, THE HEAD OF L4 WAS SEPARATED FROM THE HEAD PART AND THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7005683 ↗
• MalfunctionAug 23, 2017Mechanical Problem; Detachment Of Device Component; Mechanical Problem

  IT WAS REPORTED THAT DURING TLIF SURGERY, THE SURGEON FELT IDLE OF TORQUE WRENCH WHEN PERFORMING A FINAL TIGHTENING OF THE SCREW OF S1 SEGMENT. THE SCREW HEAD WAS DEVIATED FROM THE SCREW SHAFT WHEN IT WAS EXTRACTED. THE SCREW WAS REPLACED WITH OTHER NEW ONE AND THE SURGERY WAS COMPLETED.

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

  MAUDE report 6814986 ↗
• InjuryNov 16, 2016Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT THE SURGERY. ON (B)(6) 2016, THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE SCREW OF T12 AND L1 BACKED OUT. THEREFORE, THE SURGEON PLANNING THE REVISION SURGERY ON (B)(6) 2016. AFTER SURGERY, THE PATIENT WAS NOT USED THE CORSET.

  Patient problems: Injury; No Code Available

  MAUDE report 6107577 ↗
• MalfunctionNov 16, 2016Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT THE SURGERY. ON (B)(6) 2016, THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE SCREW OF T12 AND L1 BACKED OUT. THEREFORE, THE SURGEON PLANNING THE REVISION SURGERY ON (B)(6) 2016. AFTER SURGERY, THE PATIENT WAS NOT USED THE CORSET.

  Patient problems: Injury; No Code Available

  MAUDE report 6107537 ↗
• MalfunctionNov 16, 2016Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT THE SURGERY. ON (B)(6) 2016, THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE SCREW OF T12 AND L1 BACKED OUT. THEREFORE, THE SURGEON PLANNING THE REVISION SURGERY ON (B)(6) 2016. AFTER SURGERY, THE PATIENT WAS NOT USED THE CORSET.

  Patient problems: Injury; No Code Available

  MAUDE report 6107536 ↗
• MalfunctionNov 16, 2016Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT THE SURGERY. ON (B)(6) 2016, THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE SCREW OF T12 AND L1 BACKED OUT. THEREFORE, THE SURGEON PLANNING THE REVISION SURGERY ON (B)(6) 2016. AFTER SURGERY, THE PATIENT WAS NOT USING THE CORSET.

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

  MAUDE report 6107531 ↗
• MalfunctionApr 18, 2016Mechanical Problem; Device Operates Differently Than Expected; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON FELT THE INCLINATION OF THE SCREW HEAD WHEN HE REMOVED THE TAB OF THE SCREW AFTER THE FINAL TIGHTENING. THEN HE EXCHANGED THE SCREW TO A NEW ONE. THE SCREW HEAD WAS DEVIATED FROM THE SCREW SHAFT WHEN IT WAS EXTRACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5585662 ↗