ES2 SPINAL SYSTEM 482804755Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327002386), received between Sep 9, 2025 and Sep 23, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Detachment of Device or Device Component
A company representative reported that the tulip of an ES2 Integrated Blade Screw disengaged intra-operatively and that the screw was removed and replaced during the procedure. The procedure was completed successfully with a 20-minute surgical delay and no adverse consequence to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869301 ↗MalfunctionSep 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A CUSTOMER REPORTED THAT THE TULIP OF AN ES2 INTEGRATED BLADE SCREW DISENGAGED FROM THE SCREW INTRA-OPERATIVELY. 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 23000415 ↗
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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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