ES2 SPINAL SYSTEM 482804650Recalls & reported problems
Stryker Corporation · LONG BLADE CANNULATED SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327002195), received between Mar 4, 2016 and Dec 29, 2020 — classified as 2 injuries, 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Migration or Expulsion of Device1
- Osseointegration Problem1
Patient problems
- Injury3
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING REMOVAL OF THE SCREW IN S1, THE ES2 INTEGRATED BLADE SCREW SHAFT FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY; HOWEVER, THE TIP OF THE SCREW WAS LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11088499 ↗InjuryOct 8, 2019Fracture
A PHYSICIAN REPORTED REVISION SURGERY TO EXPLANT A MIGRATED TRITANIUM PL CAGE AND A FRACTURED ES2 INTEGRATED BLADE SCREW. THE PATIENT REPORTED EXPERIENCING PAIN. THIS REPORT CAPTURES THE ES2 INTEGRATED BLADE SCREW.
Patient problems: Injury; Pain
MAUDE report 9167056 ↗InjuryJul 22, 2019Osseointegration Problem; Break; Osseointegration Problem; Appropriate Device Problem Term/Code Not Available
THE SURGEON NOTIFIED STRYKER OF A REVISION WHICH TOOK PLACE (B)(6) 2019 TO REPLACE A BROKEN ES2 INTEGRATED BLADE SCREW IMPLANTED AT 4-1 LEVEL.
Patient problems: Injury
MAUDE report 8811604 ↗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 5480363 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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