ES2 SPINAL SYSTEM 482802655Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327001969), received between Sep 9, 2019 and Sep 9, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
- Difficult to Remove1
- Fracture1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2019Break; Fracture; Difficult to Remove; Fracture
IT WAS REPORTED THAT PATIENT PRESENTED WITH PAIN, X-RAY CONFIRMED THE BREAKAGE OF AN ES2 INTEGRATED SCREW AT L3 RIGHT. DURING REVISION SURGERY ON (B)(6) 2019, THE PROXIMAL END OF THE BROKEN SCREW WAS REMOVED, HOWEVER, THE DISTAL END OF THE SCREW COULD NOT BE EXPLANTED AND REMAINS IN THE VERTEBRA L3 LEVEL. A NEW SCREW WAS IMPLANTED AND THE CONSTRUCT WAS EXTENDED BY ONE LEVEL.
Patient problems: Pain
MAUDE report 8977793 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
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- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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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