ES2 SPINAL SYSTEM 482804660Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327002362), received between Apr 6, 2018 and Sep 17, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 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.
Most reported problems
Device problems
- Fracture2
- Appropriate Device Problem Term/Code Not Available1
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
- Injury1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2019Fracture; Appropriate Device Problem Term/Code Not Available; Fracture
A PHYSICIAN REPORTED A POST-OPERATIVE FRACTURE OF AN ES2 INTEGRATED BLADE SCREW PLACED ON THE RIGHT SIDE AT S1. REVISION SURGERY IS NOT PLANNED AND THERE HAS BEEN NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9079499 ↗InjuryApr 6, 2018Fracture; Fracture; Material Fragmentation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOSCOPE POSTERIOR FIXATION OF TH9 - L2. THE SURGICAL PROCEDURE WAS COMPLETED SMOOTHLY, BUT AFTER REVIEWING THE X RAY, THE TAB OF THE RIGHT SCREW WAS NOT PROPERLY BROKEN AND REMAINED IN PATIENT'S BODY. ONLY THE RELEVANT PART WAS THEN OPENED IN THE ICU TO BREAK THE TAB OFF THE SCREW AND OUT OF THE PATIENT'S BODY. REMOVAL WAS SUCCESSFUL.
Patient problems: Device Embedded In Tissue or Plaque; Injury
MAUDE report 7402146 ↗
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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