ES2 SPINAL SYSTEM 48280232Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613327096200), received between Mar 8, 2016 and Sep 17, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810063 ↗
• MalfunctionSep 17, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810058 ↗
• MalfunctionSep 17, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810039 ↗
• MalfunctionSep 17, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809863 ↗
• MalfunctionSep 8, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50680253 ↗
• MalfunctionSep 1, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50551599 ↗
• MalfunctionSep 1, 2026Fracture

  Patient problems: Insufficient Information

  MAUDE report 50550582 ↗
• InjuryMar 5, 2026Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT AN ES2 NITINOL K-WIRE BLUNT FRACTURED INTRA-OPERATIVELY. IT WAS FURTHER REPORTED THAT A LARGER INCISION WAS MADE INTRA-OPERATIVELY TO RETRIEVE THE FRACTURED COMPONENT AND ADDITIONAL X-RAYS WERE PERFORMED. THE PROCEDURE WAS COMPLETED WITH A FIVE MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519743 ↗
• MalfunctionSep 4, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT AN ES2 K-WIRE FRACTURED INTRA-OPERATIVELY IN THE PATIENT'S VERTEBRA. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS CONVERTED TO A OPEN SURGERY TO ATTEMPT TO REMOVE THE FRACTURED COMPONENT, HOWEVER IT REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964572 ↗
• MalfunctionApr 28, 2023Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF Q1 2023 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES FIVE INSTANCES OF INTRAOPERATIVE ES2 LE NITINIOL KWIRE TIP FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16838119 ↗
• MalfunctionOct 28, 2022Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN ES2 K-WIRE FRACTURED DURING SURGERY AND REMAINS LODGED IN THE PATIENT'S BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693185 ↗
• MalfunctionJan 27, 2022Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE AN ES2 K-WIRE FRACTURED INTRA-OPERATIVELY. THE FRACTURED PIECE WAS REMOVED AND SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366583 ↗
• MalfunctionJan 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF AN ES2 K-WIRE SNAPPED OFF DURING SCREW INSERTION. THE BROKEN PIECE WAS REMOVED AND SURGERY WAS SUCCESSFULLY COMPLETED WITH A 5 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13349158 ↗
• InjuryMay 6, 2021Fracture; Fracture

  IT WAS REPORTED THAT A PORTION OF AN ES2 KWIRE BROKE OFF INSIDE THE PATIENT INTRA-OPERATIVELY. THE PATIENT WAS REVISED THE NEXT DAY IN ORDER TO REMOVE THE FRACTURED PIECE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNSPECIFIED SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784935 ↗
• MalfunctionSep 25, 2018Fracture; Detachment of Device or Device Component; Fracture

  IT WAS REPORTED THAT DURING TLIF SURGERY, A SHORT BLADE SCREW WAS INSERTED VIA K-WIRE WITHOUT ANY PROBLEMS. HOWEVER, IT WAS FOUND BY POST OPERATIVE RADIOGRAPH THAT A PART OF THE K-WIRE WAS BEING LEFT IN S1. THE FRAGMENT OF K-WIRE WAS NOT RETRIEVED. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.

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

  MAUDE report 7908547 ↗
• MalfunctionAug 17, 2017Fracture; Material Integrity Problem; Break; Fracture; Material Fragmentation; Material Integrity Problem

  IT WAS REPORTED THAT; WHEN THE SURGEON WAS INSERTING THE PEDICLE SCREW TO LEFT, THE K-WIRE WAS BROKEN BECAUSE THE INSERTION ANGLE OF THE SCREW WAS DEVIATED. THE SCREW WAS REINSERTED BUT THE FRAGMENT OF THE WIRE (APPROX 50MM LENGTH) WAS REMAINED TO THE PATIENT.

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

  MAUDE report 6800031 ↗
• MalfunctionJul 17, 2017Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE PHARMACIST SEND US A FAX AND REPORTED THAT : " DURING A SURGERY PERFORMED BY SURGEON RELATING TO AN ARTHRECTOMY AND AN ARTHRODESIS IN L4-L5, THE SPINDLE BROKE INTRA-VERTEBRAL" FURTHER INFO IS EXPECTED. ON 06/26/2017 - UPDATE / THE SALES REP SENT THE INTAKE FORM FILLED AND PROVIDED FURTHER INFO REGARDING THE EVENT AS FOLLOWED: "THE NEUROSURGEON AT THE HOSPITAL REPORTED TO OUR SALES REP THE FOLLOWING EVENT : " DURING A PERCUTANEOUS SURGERY (HERNIATED DISC REVISION SURGERY), SURGEON USED THE POSTERIOR FIXATION SYSTEM. SO HE USED KIRSCHNER PINS TO GUIDE THE INSTRUMENTATION NEEDED TO POSITION THE PEDICLE SCREWS. FOR EACH SCREW TO POSITION THE SURGEON HAS FOLLOWED THE FOLLOWING STEPS: PEDICULAR SCREW USING A JAM SHIDI / POSITIONING A KIRSCHNER PIN IN THE JAM SHIDI / USING THE DILATORS / USING A TAP / POSITIONING THE SCREW. FOR EACH SCREW A NEW KIRSCHNER SPINDLE WAS USED. THE EVENT HAPPENED BEFORE THE POSITIONING OF THE SECOND SCREW (L4) DURING THE USE OF THE TAP. SINCE THE TAP HAD A DEVIATED PROGRESSION WITH RESPECT TO THE AXIS OF THE KIRSCHNER SPINDLE, THE SURGEON CARRIED OUT A SCOPIC CHECK (SEE PHOTO ATTACHED IN THE INTAKE TAB). THE PICTURE SHOWS THAT THE PIN HAD BROKEN AT THE BASE

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

  MAUDE report 6719988 ↗
• MalfunctionMay 26, 2017Bent; Break; Fracture; Difficult to Remove; Fracture

  IT WAS REPORTED THAT: THE SALES REPRESENTATIVE REPORTED THE FOLLOWING EVENT : " IN PERCUTANEOUS SURGERY, THE SURGEON, USED THE FIXATION SYSTEM. HE USED PINS TO GUIDE THE INSTRUMENTATION NEEDED TO POSITION THE PEDICLE SCREWS. FOR EACH SCREW TO POSITION THE SURGEON HAS FOLLOWED THE FOLLOWING STEPS: SCREW PEDICLE WITH A JAM SHIDI / POSITIONING A PIN IN THE JAM SHIDI / USING THE DILATORS / USING A TAP / POSITIONING THE SCREW. FOR EACH SCREW A NEW SPINDLE WAS USED. THE EVENT OCCURRED BEFORE THE 4TH AND LAST SCREW WAS POSITIONED. WHEN THE SURGEON USED THE TAP, HE REALIZED THAT THE TAP HAD NO GRIP IN THE PATIENT'S BONE. A X-RAY SHOT WAS THUS PERFORMED, WHICH SHOWED THAT THE PIN HAD BENT AT ITS BASE ). SINCE THIS CURVATURE DID NOT ALLOW THE TAP TO PROGRESS ALONG THE PIN, THE SURGEON REPEATEDLY TRIED TO REMOVE THIS PIN FROM THE PATIENT'S VERTEBRA (BY PULLING IT). WITH THE PIN BLOCKED IN THE VERTEBRA, SURGEON ATTEMPTED TO SLIDE A JAM SHIDI ALONG THIS PIN TO FACILITATE ITS REMOVAL. ONCE THE JAM SHIDI WAS POSITIONED, THE SURGEON AGAIN ATTEMPTED TO PULL THE PIN REPEATEDLY. ONCE REMOVED THE SURGEON REALIZED THAT THE PIN WAS BROKEN AND THAT A PIECE HAD REMAINED STUCK IN THE PATIENT'S PEDICLE. A X

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

  MAUDE report 6595304 ↗
• MalfunctionMar 21, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; DURING A CASE WITH A NEUROSURGEON IN A PUBLIC HOSPITAL, 2 K-WIRES BROKE WHILE INSERTING INTO THE VERTEBRAL BODY THROUGH THE JAMSHIDI NEEDLE. THE SURGEON WAS HOLDING THE WIRES WITH A WIRE HOLDER AND IMPACTING WITH A SMALL MALLET ON THE HOLDER ITSELF, NO IMPACTION WAS APPLIED ONTO THE WIRES ITSELF. BOTH TIMES THE SURGEON WAS ABLE TO WITHDRAW THE WIRES AND INSERT ANOTHER ONE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6420270 ↗
• MalfunctionMar 20, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; DURING A CASE WITH A NEUROSURGEON IN A PUBLIC HOSPITAL, 2 K-WIRES BROKE WHILE INSERTING INTO THE VERTEBRAL BODY THROUGH THE JAMSHIDI NEEDLE. THE SURGEON WAS HOLDING THE WIRES WITH A WIRE HOLDER AND IMPACTING WITH A SMALL MALLET ON THE HOLDER ITSELF, NO IMPACTION WAS APPLIED ONTO THE WIRES ITSELF. BOTH TIMES THE SURGEON WAS ABLE TO WITHDRAW THE WIRES AND INSERT ANOTHER ONE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6419462 ↗
• MalfunctionMar 8, 2016Material Integrity Problem; Break; Detachment Of Device Component; Material Integrity Problem

  IT WAS REPORTED THAT THE K WIRE BROKE OFF IN PATIENT PEDICEL WHILE USING TAP TO PREPARE HOLE FOR SCREW.

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

  MAUDE report 5486485 ↗