ES2 SPINAL SYSTEM 482804740Recalls & reported problems
Stryker Corporation · LONG 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327002225), received between Mar 4, 2016 and Apr 8, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Adverse Event Without Identified Device or Use Problem1
- Detachment Of Device Component1
- Device Dislodged or Dislocated1
- Fracture1
- Migration or Expulsion of Device1
Patient problems
- Injury1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TAB OF AN ES2 BLADE SCREW FRACTURED INTRA-OPERATIVELY AND REMAINED IN THE PATIENT. SUBSEQUENTLY, REVISION SURGERY WAS PERFORMED THE NEXT DAY WHERE THE SCREW WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14053119 ↗MalfunctionDec 13, 2017Detachment Of Device Component; Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT; SCREW HEAD POPPED OFF DURING FINAL TIGHTENING. THE SAME SIZE SCREW WAS USED AS A REPLACEMENT WITH NEW BLOCKERS
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7112473 ↗MalfunctionMar 4, 2016Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED TO REPLACE THE ROD THAT MIGRATED.
Patient problems: Injury; No Code Available
MAUDE report 5480364 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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