ES2 SPINAL SYSTEM 482802645Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327001945), received between Aug 22, 2016 and Nov 21, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Device Reprocessing Problem; Insufficient Device Problem Information; Device Reprocessing Problem; Insufficient Device Problem Information

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623162 ↗
• InjuryMar 26, 2025Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT A PATIENT WITH PAIN WAS REVISED TO ADDRESS A MIGRATED ES2 INTEGRATED BLADE SCREW.

  Patient problems: Pain

  MAUDE report 21700643 ↗
• MalfunctionApr 25, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; THE EXTRACTION SURGERY WAS PERFORMED DUE TO HEALING OF THE DISEASE. DURING THE EXTRACTION SURGERY, THE BREAKAGE OF L5 RIGHT SIDE SCREW WAS FOUND. THE TIP OF THE SCREW WAS REMAINED TO THE PATIENT AND THE SURGERY WAS FINISHED.

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

  MAUDE report 6518666 ↗
• MalfunctionApr 18, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2015 IMPLANTED FROM L4 TO L5 BY PLIF USING SOME SCREWS. IMPLANTED 4 SCREW AND L4 LEFT, L5 RIGHT. ON (B)(6) 2016, IMPLANTED TO EXTEND BY PEEK TO S FROM L5 BY PLIF. IMPLANTED 2 SCREWS FOR SI AND FIXED FOR L4-S BY SCREW(S1RIGHT). UNK DATE, IT WAS CONFIRMED 3 SCREW WERE BROKEN(L4LEFT,L5RIGHT,S1RIGHT). ON (B)(6) 2017 REMOVED BROKEN 3 SCREW AND IMPLANTED NEW SCREWS.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6501560 ↗
• MalfunctionApr 18, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2015 IMPLANTED FROM L4 TO L5 BY PLIF USING SOME SCREWS. IMPLANTED 4 SCREW AND L4 LEFT, L5 RIGHT. ON (B)(6) 2016, IMPLANTED TO EXTEND BY PEEK TO S FROM L5 BY PLIF. IMPLANTED 2 SCREWS FOR SI AND FIXED FOR L4-S BY SCREW (S1RIGHT). UNK DATE, IT WAS CONFIRMED 3 SCREW WERE BROKEN (L4LEFT,L5RIGHT,S1RIGHT). ON (B)(6) 2017 REMOVED BROKEN 3 SCREW AND IMPLANTED NEW SCREWS.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6501558 ↗
• InjuryApr 18, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2015 IMPLANTED FROM L4 TO L5 BY PLIF USING SOME SCREWS. IMPLANTED 4 SCREW AND L4 LEFT, L5 RIGHT. ON (B)(6) 2016, IMPLANTED TO EXTEND BY PEEK TO S FROM L5 BY PLIF. IMPLANTED 2 SCREWS FOR SI AND FIXED FOR L4-S BY SCREW(S1RIGHT). UNK DATE, IT WAS CONFIRMED 3 SCREW WERE BROKEN(L4LEFT,L5RIGHT,S1RIGHT). ON (B)(6) 2017 REMOVED BROKEN 3 SCREW AND IMPLANTED NEW SCREWS.

  Patient problems: Injury; No Code Available

  MAUDE report 6501557 ↗
• MalfunctionApr 5, 2017Detachment Of Device Component; Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  IT WAS REPORTED THAT; THIS EVENT OCCURRED AT THE FIXATION OF THE L4/5 AND THE ILIAC BONE OF THE PELVIC FRACTURE. WHEN THE FINAL TIGHTENING OF THE BLOCKER AT RIGHT L4 SCREW, THE SURGEON CONFIRMED THAT THE SCREW HEAD WAS CAME OFF FROM THE SCREW SHAFT. AFTER THAT, THE SURGEON PULLED OUT THE ROD AND CONFIRMED THAT THE SCREW OF THE L5 AND ILIAC BONE WHICH WAS ALREADY IMPLANTED. THE TWO SCREW HEADS WERE CAME OFF FROM THE SCREW SHAFT TOO. THEREFORE, THE THREE SCREWS WERE EXCHANGED THE NEW OTHER SIZE SCREWS AND THE OPERATION WAS SUCCEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6460585 ↗
• MalfunctionFeb 7, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT DURING A PERCUTANEOUS ARTHRODESIS, INSERTION OF 4 SCREWS INTO THE PEDICLES OF THE PATIENT. THEN, TO PROCEED THE DISCECTOMY TO INSERT A ROTATIVE LUMBAR CAGE INTO THE INTRADISCAL SPACE, THE SURGEON INSTALLED THE PBR SPACER. HE INTRODUCED A SHORT PIN INTO EACH SUPPORTING SCREWS OF THE SPACER. TO INSERT THE PIN INTO THE THREAD OF THE SCREW, THE SURGEON USED A COUNTER TORQUE KEY TO HOLD THE SCREW. WHEN INSERTING THE PIN INTO THE THREAD, THE SHORT FINS OF THE SCREW BROKE. THEY FRACTURED AT THE LEVEL OF THE SPACE PROVIDED TO ALLOW BREAKING AT THE END OF THE INTERVENTION. THE SURGEON REPLACED THE SCREW BY A NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6307068 ↗
• MalfunctionAug 22, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT; PLIF (L4-5) WAS PERFORMED ON (B)(6) 2015. ADDITIONAL FIXATION (L5-S1) WAS PERFORMED ON (B)(6) 2016. 1 MONTH AFTER THE SECOND SURGERY, THE BREAKAGE OF S1 SCREW WAS FOUND. THE REVISION SURGERY IS NOT PLANNED AT PRESENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5894734 ↗