ES2 SPINAL SYSTEM 482804645Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327002188), received between Jun 25, 2018 and Nov 22, 2025 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT TWO ES2 INTEGRATED SCREWS FRACTURED POST-OPERATIVELY. NO ADVERSE CONSEQUENCES WERE REPORTED. THE FRACTURED SCREWS WERE OBSERVED IN A PLANNED REMOVAL SURGERY APPROXIMATELY THREE YEARS POST-OPERATIVELY. THE PROXIMAL PORTION OF THE SCREWS WERE EXPLANTED; HOWEVER THE DISTAL SHANK OF THE SCREWS REMAINED IN THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23625683 ↗
• MalfunctionNov 22, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT TWO ES2 INTEGRATED SCREWS FRACTURED POST-OPERATIVELY. NO ADVERSE CONSEQUENCES WERE REPORTED. THE FRACTURED SCREWS WERE OBSERVED IN A PLANNED REMOVAL SURGERY APPROXIMATELY THREE YEARS POST-OPERATIVELY. THE PROXIMAL PORTION OF THE SCREWS WERE EXPLANTED, HOWEVER THE DISTAL SHANK OF THE SCREWS REMAINED IN THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23625679 ↗
• InjuryJan 21, 2022Migration; Migration

  IT IS REPORTED THAT REVISION SURGERY WAS PERFORMED TO REMOVE AN ES2 SCREW THAT HAD MIGRATED AND WAS NOW CAUSING THE PATIENT PAIN. DURING THE REVISION SURGERY, WHILE THE SURGEON WAS REMOVING A DIFFERENT SCREW, THE SCREW APPEARED TO HAVE FRACTURED. UPON REVIEW OF THE PRE-OPERATIVE X-RAY, THE SURGEON NOTICED THAT THE OTHER ES2 SCREW HAD FRACTURED BEFORE THE REVISION SURGERY. BOTH SCREWS WERE REMOVED. THIS REPORT CAPTURES THE MIGRATED SCREW.

  Patient problems: Pain

  MAUDE report 13315323 ↗
• InjurySep 29, 2020Migration; Migration

  A PHYSICIAN REPORTED THAT A ES2 INTEGRATED BLADE SCREW AT S1 FRACTURED AND THE CONTRALATERAL ES2 INTEGRATED BLADE SCREW AT WAS LOOSE IN THE BONE. THE PATIENT HAS BEEN REVISED. THIS REPORT REPRESENTS THE MIGRATED SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10602865 ↗
• InjurySep 29, 2020Fracture; Fracture

  A PHYSICIAN REPORTED THAT A ES2 INTEGRATED BLADE SCREW AT S1 FRACTURED AND THE CONTRALATERAL ES2 INTEGRATED BLADE SCREW AT WAS LOOSE IN THE BONE. THE PATIENT HAS BEEN REVISED. THIS REPORT REPRESENTS THE FRACTURED SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10602740 ↗
• InjuryJul 9, 2020Biocompatibility; Biocompatibility

  A SURGEON REPORTED THAT A PATIENT MAY HAVE EXPERIENCED METALLOSIS AT THE L4 LEVEL WHILST IMPLANTED WITH TWO ES2 SCREWS AND TWO ES2 HEX RODS. THE PATIENT WAS UNDERGOING A SCHEDULED REVISION SURGERY TO EXTEND THE CONSTRUCT TO S1 WHEN THE SURGEON NOTED, "METALLOSIS AROUND THE L4 SCREWS," AND, "SOME EVIDENCE OF DISCOLOURATION OF THE SURROUNDING TISSUE ADJACENT TO THE SCREWS." SURGERY WAS COMPLETED AS PLANNED; THE RODS WERE EXPLANTED AND REPLACED WITH LONGER RODS AND THE L4 SCREWS WERE REPLACED. THIS REPORT REPRESENTS THE FIRST OF THE TWO SCREWS.

  Patient problems: Injury

  MAUDE report 10254814 ↗
• InjuryJul 9, 2020Biocompatibility; Biocompatibility

  A SURGEON REPORTED THAT A PATIENT MAY HAVE EXPERIENCED METALLOSIS AT THE L4 LEVEL WHILST IMPLANTED WITH TWO ES2 SCREWS AND TWO ES2 HEX RODS. THE PATIENT WAS UNDERGOING A SCHEDULED REVISION SURGERY TO EXTEND THE CONSTRUCT TO S1 WHEN THE SURGEON NOTED, "METALLOSIS AROUND THE L4 SCREWS," AND, "SOME EVIDENCE OF DISCOLOURATION OF THE SURROUNDING TISSUE ADJACENT TO THE SCREWS." SURGERY WAS COMPLETED AS PLANNED; THE RODS WERE EXPLANTED AND REPLACED WITH LONGER RODS AND THE L4 SCREWS WERE REPLACED. THIS REPORT REPRESENTS THE SECOND OF THE TWO SCREWS.

  Patient problems: Injury

  MAUDE report 10254714 ↗
• MalfunctionNov 27, 2019Migration; Migration or Expulsion of Device; Migration

  COMPANY REPRESENTATIVE REPORTED THAT DURING AN EXTENSION OF FUSION, AN ES2 BLOCKER WAS FOUND TO MIGRATED/PULLED-OUT. THE DEVICE WAS REPLACED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 9387034 ↗
• MalfunctionJun 18, 2019Fracture; Break; Fracture

  TWO SCREWS WERE REPORTED TO HAVE BROKEN POST-OPERATIVELY. ONE SCREW WAS NOTED BROKEN VIA X-RAY AND THE OTHER SCREW WAS NOTED BROKEN DURING THE REVISION SURGERY. IT WAS REPORTED THAT THE RIGHT-SIDE SCREW WAS REPLACED BUT THAT THE LEFT-SIDE SCREW WAS NOT REPLACED BECAUSE FUSION HAD OCCURRED. THIS RECORD REPRESENTS THE LEFT-SIDE SCREW.

  Patient problems: Injury

  MAUDE report 8707623 ↗
• InjuryJun 18, 2019Fracture; Break; Fracture

  TWO SCREWS WERE REPORTED TO HAVE BROKEN POST-OPERATIVELY. ONE SCREW WAS NOTED BROKEN VIA X-RAY AND THE OTHER SCREW WAS NOTED BROKEN DURING THE REVISION SURGERY. IT WAS REPORTED THAT THE RIGHT-SIDE SCREW WAS REPLACED BUT THAT THE LEFT-SIDE SCREW WAS NOT REPLACED BECAUSE FUSION HAD OCCURRED. THIS RECORD REPRESENTS THE RIGHT-SIDE SCREW.

  Patient problems: Injury

  MAUDE report 8707400 ↗
• InjuryJun 25, 2018Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration; Migration

  THE PATIENT REPORTED THAT A CAGE WHICH WAS IMPLANTED ON (B)(6) 2014, HAD SLID OUT FROM L4/L5 AND HE WILL UNDERGO CORRECTIVE SURGERY (B)(6) 2018 DUE TO EXCRUCIATING PAIN. PATIENT REPORTED THE SAME TYPE OF PAIN RADIATING DOWN RIGHT LEG, NEUROPATHY, AND NUMBNESS IN RIGHT FOOT, WHICH GOT WORSE SINCE (B)(6) 2014, WHEN SYMPTOMS STARTED. DEVICE WILL BE REMOVED. IN ADDITION, PATIENT REPORTED THAT X-RAYS SHOW, CAGE MOVED ABOUT 3/4 INCH TOWARD POSTERIOR AND RIGHT AND PHYSICIAN STATED, "IT IS PARTIALLY FUSED IN A BAD PLACE. HE HAS TO CUT IT OUT." PATIENT ADDITIONALLY REPORTED THAT, "THE CT SCANS SHOW HALO AROUND SCREWS WHICH MIGHT INDICATE LOOSENING ACCORDING TO THE PHYSICIAN."

  Patient problems: Failure of Implant; Injury; Neuropathy; Numbness; Pain

  MAUDE report 7635291 ↗
• InjuryJun 25, 2018Device Operates Differently Than Expected; Migration; Migration

  THE PATIENT REPORTED THAT A CAGE WHICH WAS IMPLANTED ON (B)(6) 2014, HAD SLID OUT FROM L4/L5 AND HE WILL UNDERGO CORRECTIVE SURGERY(B)(6) 2018 DUE TO EXCRUCIATING PAIN. PATIENT REPORTED THE SAME TYPE OF PAIN RADIATING DOWN RIGHT LEG, NEUROPATHY, AND NUMBNESS IN RIGHT FOOT, WHICH GOT WORSE SINCE (B)(6) 2014, WHEN SYMPTOMS STARTED. DEVICE WILL BE REMOVED. IN ADDITION, PATIENT REPORTED THAT X-RAYS SHOW, CAGE MOVED ABOUT 3/4 INCH TOWARD POSTERIOR AND RIGHT AND PHYSICIAN STATED, "IT IS PARTIALLY FUSED IN A BAD PLACE. HE HAS TO CUT IT OUT." PATIENT ADDITIONALLY REPORTED THAT, "THE CT SCANS SHOW HALO AROUND SCREWS WHICH MIGHT INDICATE LOOSENING ACCORDING TO THE PHYSICIAN."

  Patient problems: Injury; Neuropathy; Numbness; Pain

  MAUDE report 7635183 ↗