ES2 SPINAL SYSTEM 482802540Recalls & 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
- 12
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327001884), received between Apr 19, 2018 and Feb 20, 2026 — classified as 10 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Migration” (10 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
- Migration10
- Fracture3
- Break1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Pain2
- Injury1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2026Migration
InjuryFeb 20, 2026Migration
MalfunctionJul 18, 2022Fracture; Fracture
A PHYSICIAN REPORTED THAT AN ES2 POLYAXIAL SCREW INSERTED INTO TO THE S1 LEFT SIDE BROKE OFF POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED WITH THE BROKEN SCREW AND THE BLOCKER BEING REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15048388 ↗InjuryAug 31, 2021Migration; Migration
IT WAS REPORTED THAT THREE ES2 INTEGRATED BLADE SCREWS MIGRATED POST-OPERATIVELY AT T12, L2 AND L3. THE PATIENT WAS REVISED TO REMOVE THE MIGRATED SCREWS. THIS RECORD CAPTURES THE THIRD OF THREE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12392678 ↗InjuryAug 31, 2021Migration; Migration
IT WAS REPORTED THAT THREE ES2 INTEGRATED BLADE SCREWS MIGRATED POST-OPERATIVELY AT T12, L2 AND L3. THE PATIENT WAS REVISED TO REMOVE THE MIGRATED SCREWS. THIS RECORD CAPTURES THE FIRST OF THREE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12392674 ↗InjuryOct 28, 2020Migration; Migration
A PHYSICIAN HAS REPORTED THAT A PATIENT HAS UNDERGONE REVISION SURGERY TO ADDRESS FIVE MIGRATED ES2 SCREWS, APPROXIMATELY TWO-MONTHS AFTER IMPLANTATION. THIS RECORD CAPTURES THE FOURTH OF FIVE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10752440 ↗InjuryOct 28, 2020Migration; Migration
A PHYSICIAN HAS REPORTED THAT A PATIENT HAS UNDERGONE REVISION SURGERY TO ADDRESS FIVE MIGRATED ES2 SCREWS, APPROXIMATELY TWO-MONTHS AFTER IMPLANTATION. THIS RECORD CAPTURES THE FIFTH OF FIVE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10752373 ↗InjuryOct 28, 2020Migration; Migration
A PHYSICIAN HAS REPORTED THAT A PATIENT HAS UNDERGONE REVISION SURGERY TO ADDRESS FIVE MIGRATED ES2 SCREWS, APPROXIMATELY TWO-MONTHS AFTER IMPLANTATION. THIS RECORD CAPTURES THE SECOND OF FIVE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10752367 ↗InjuryOct 28, 2020Migration; Migration
A PHYSICIAN HAS REPORTED THAT A PATIENT HAS UNDERGONE REVISION SURGERY TO ADDRESS FIVE MIGRATED ES2 SCREWS, APPROXIMATELY TWO-MONTHS AFTER IMPLANTATION. THIS RECORD CAPTURES THE THIRD OF FIVE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10752346 ↗InjuryOct 28, 2020Migration; Migration
A PHYSICIAN HAS REPORTED THAT A PATIENT HAS UNDERGONE REVISION SURGERY TO ADDRESS FIVE MIGRATED ES2 SCREWS, APPROXIMATELY TWO-MONTHS AFTER IMPLANTATION. THIS RECORD CAPTURES THE FIRST OF FIVE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10752320 ↗InjuryJun 21, 2019Migration; Fracture; Device Dislodged or Dislocated; Migration
PRIMARY SURGERY USING ES2 SYSTEM WAS PERFORMED (B)(6) 2017. IT WAS REPORTED THAT THE SCREW DEVIATED FROM THE VERTEBRAL BODY POST-OPERATIVELY AND THE CAGE FRACTURED AT L3/4. PATIENT WAS REVISED ON (B)(6) 2019. THIS RECORD REPRESENTS THE CAGE
Patient problems: Injury
MAUDE report 8724915 ↗MalfunctionApr 19, 2018Fracture; Break; Fracture
IT WAS REPORTED THAT DURING A REVISION SURGERY, THE SCREW BROKE. THERE WAS NO ASSOCIATED SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH THE BROKEN PART REMAINING IN THE BONE. THE CAUSE OF REVISION SURGERY IS UNKNOWN.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 7444968 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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.
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