ES2 SPINAL SYSTEM 482802740Recalls & reported problems
Stryker Corporation · SHORT BLADE CANNULATED SCREW · Class 2 · Implant
All models of ES2 SPINAL SYSTEM (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613327002003), received between Mar 22, 2016 and Feb 19, 2026 — classified as 11 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Migration” (9 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.
Reports received per month
Most reported problems
Device problems
- Migration9
- Fracture5
- Material Separation4
- Break2
- Device Dislodged or Dislocated2
- Loose or Intermittent Connection2
- Migration or Expulsion of Device2
- Detachment Of Device Component1
Patient problems
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient4
- Injury2
- No Code Available2
- Bone Fracture(s)1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2026Migration
A CUSTOMER REPORTED THAT APPROXIMATELY 4 YEARS POST-OPERATIVELY A PATIENT WAS REVISED TO ADDRESS SIX ES2 INTEGRATED BLADE SCREWS THAT HAD MIGRATED. THIS REPORT CAPTURES THE SECOND OF SIX SCREWS.
Patient problems: Insufficient Information
MAUDE report 24394512 ↗InjuryFeb 19, 2026Migration
A CUSTOMER REPORTED THAT APPROXIMATELY 4 YEARS POST-OPERATIVELY A PATIENT WAS REVISED TO ADDRESS SIX ES2 INTEGRATED BLADE SCREWS THAT HAD MIGRATED. THIS REPORT CAPTURES THE SIXTH OF SIX SCREWS.
Patient problems: Insufficient Information
MAUDE report 24394507 ↗InjuryFeb 19, 2026Migration
InjuryFeb 19, 2026Migration
InjuryFeb 19, 2026Migration
InjuryFeb 19, 2026Migration
MalfunctionJan 12, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated
A HEALTH PROFESSIONAL REPORTED THAT THE TULIP OF AN ES2 INTEGRATED BLADE SCREW DISENGAGED UPON REMOVAL OF THE SCREW INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24046505 ↗MalfunctionApr 19, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A TRITANIUM PL CAGE AND AN ES2 SCREW THAT MIGRATED POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT DURING THE REVISION SURGERY, IT WAS OBSERVED THAT TWO ADDITIONAL ES2 SCREWS MIGRATED POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS WORKING IN THE FIELDS ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE FIRST OF THE TWO ADDITIONAL SCREWS OBSERVED DURING THE REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 21870025 ↗MalfunctionApr 19, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A TRITANIUM PL CAGE AND AN ES2 SCREW THAT MIGRATED POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT DURING THE REVISION SURGERY, IT WAS OBSERVED THAT TWO ADDITIONAL ES2 SCREWS MIGRATED POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS WORKING IN THE FIELDS ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE SECOND OF THE TWO ADDITIONAL SCREWS OBSERVED DURING THE REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 21870024 ↗InjuryApr 4, 2025Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY 9 MONTHS POST-OPERATIVELY, IMAGING REVEALED A FRACTURED ES2 INTEGRATED BLADE SCREW AT RIGHT-SIDE L3. IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY ONE YEAR POST-OPERATIVELY AND THAT A PORTION OF THE SCREW WAS EXPLANTED, HOWEVER THE DISTAL END OF THE FRACTURED SCREW SHANK REMAINED IMPLANTED IN THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21773285 ↗InjuryFeb 4, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A TRITANIUM PL CAGE AND AN ES2 SCREW THAT MIGRATED POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT DURING THE REVISION SURGERY, IT WAS OBSERVED THAT TWO ADDITIONAL ES2 SCREWS MIGRATED POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS WORKING IN THE FIELDS ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE SCREW THAT WAS BEING REVISED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21306167 ↗InjuryDec 23, 2020Fracture; Material Separation; Fracture; Material Separation
IT WAS REPORTED THAT APPROXIMATELY 3 WEEKS FOLLOWING THE INITIAL SURGERY, AN ES2 INTEGRATED BLADE SCREW AND MANTIS STRAIGHT ROD FRACTURED POST-OPERATIVELY. REVISION SURGERY HAS BEEN PERFORMED. THIS RECORD REPRESENTS THE BLADE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11069519 ↗MalfunctionOct 19, 2020Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT RECEIVED REVISION SURGERY APPROXIMATELY FOUR MONTHS POST OPERATIVELY DUE TO A LOOSE SCREW. DURING THE REVISION SURGERY, THE SURGEON FOUND THAT AN ES2 INTEGRATED BLADE SCREW TULIP DISENGAGED AND A BLOCKER MIGRATED. THE SCREWS WERE THEN REPLACED AND THE CONSTRUCT WAS EXTENDED. THIS REPORT REPRESENTS THE ES2 INTEGRATED BLADE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10701977 ↗MalfunctionFeb 28, 2020Fracture; Fracture
IT WAS REPORTED THAT AN ES2 INTEGRATED BLADE SCREW TAB THREADING FRACTURED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10 MINUTE SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9772018 ↗MalfunctionNov 2, 2018Fracture; Fracture
IT WAS REPORTED THAT THE BLADE FRACTURED DURING A SURGERY. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8035186 ↗InjuryMay 11, 2018Migration or Expulsion of Device; Loose or Intermittent Connection; Migration or Expulsion of Device
IN THE INITIAL SURGERY PERFORMED ON (B)(6) 2016, SCREWS WERE IMPLANTED FOR ADULT SPINAL DEFORMITY DISEASE. THE REVISION SURGERY PERFORMED ON (B)(6) 2018 WAS CARRIED OUT AGAINST LOOSENING OF L6 AND S1 OF SCREWS. SCREWS WERE REPLACED.
Patient problems: Injury; No Code Available
MAUDE report 7506199 ↗InjuryMay 11, 2018Migration or Expulsion of Device; Loose or Intermittent Connection; Migration or Expulsion of Device
IN THE INITIAL SURGERY PERFORMED ON (B)(6) 2016, SCREWS WERE IMPLANTED FOR ADULT SPINAL DEFORMITY DISEASE. THE REVISION SURGERY PERFORMED ON (B)(6) 2018 WAS CARRIED OUT AGAINST LOOSENING OF L6 AND S1 OF SCREWS. SCREWS WERE REPLACED.
Patient problems: Injury; No Code Available
MAUDE report 7506146 ↗MalfunctionFeb 26, 2018Fracture; Break; Fracture
IT WAS REPORTED THAT ONE OF THE BLADES BROKE WHEN INSERTING PEDICLE BASED RETRACTOR SCREW PIN, DURING SURGERY. THE SHORT BLADE SCREW WAS REPLACED WITH A NEW ONE. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7298016 ↗MalfunctionApr 5, 2017Break; Detachment 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: Bone Fracture(s); No Known Impact Or Consequence To Patient
MAUDE report 6460630 ↗MalfunctionMar 22, 2016Mechanical Problem; Mechanical Problem; Material Separation; Device Dislodged or Dislocated
IT WAS REPORTED THAT; UPON FINAL TIGHTENING OF SCREWS, THE SURGEON NOTICED THAT ONE OF THE BLOCKERS WAS RECESSED FURTHER INTO THE HEAD OF THE SCREW THAN THE OTHER 3 SCREWS IN THE PROCEDURE. AFTER BOTH AP AND LATERAL X-RAYS WERE PERFORMED, IT WAS REALIZED THAT THE HEAD OF THE SCREW HAD BECOME DISLOCATED FROM THE SHAFT OF THE SCREW AND SEPARATED. THE SCREW WAS REMOVED AND REPLACED WITH A RESCUE SCREW. UPON FINAL TIGHTENING WITH THE RESCUE SCREW, THE OTHER SCREW ON THE SAME SIDE ALSO BECAME DISLOCATED. AGAIN, THIS SCREW WAS ALSO REPLACED WITH A RESCUE SCREW. BOTH SCREWS WERE SAVED FOR FURTHER EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5516150 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page