ES2 SPINAL SYSTEM 482802640Recalls & reported problems
Stryker Corporation · SHORT BLADE CANNULATED SCREW · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327001938), received between Dec 28, 2017 and Feb 6, 2026 — classified as 1 injury, 3 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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Detachment Of Device Component1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Fracture; Device Dislodged or Dislocated
A HEALTH PROFESSIONAL REPORTED THAT THE TULIP OF AN ES2 INTEGRATED BLADE SCREW DISENGAGED 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 24281724 ↗InjuryAug 31, 2021Migration; Migration
IT WAS REPORTED THAT THREE ES2 INTEGRATED BLADE SCREWS MIGRATED POST-OPERATIVELY AT T12, L2 AND L3. THE PATIENT WAS REVISED TO REMOVE THE MIGRATED SCREWS. THIS RECORD CAPTURES THE SECOND OF THREE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12392700 ↗MalfunctionJan 4, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE POSTERIOR FIXATION FROM L2 TO S WAS DONE AT (B)(6). AT (B)(6), THE SCREW HEAD WAS CAME OFF FROM THE SCREW WAS CONFIRMED AT CT. HOWEVER, THE PATIENT HAD NO SYMPTOMS AND THE REVISION WAS NOT DONE. THE PART OF THE COMPLAINT WAS L3 OR L4.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7163339 ↗MalfunctionDec 28, 2017Fracture
IT WAS REPORTED THAT; SURGEON PERFORMED A PERCUTANEOUS SPINAL FUSION T11 TO L4 ON (B)(6)2016 TO TREAT AN L2 BURST FRACTURE. ON FOLLOW UP VISIT, 11/30/2017, AN X-RAY REVEALED WHAT APPEARS TO BE A BROKEN SCREW AT RIGHT L4. NO REMEDIATION WAS PERFORMED. SURGEON INFORMED REPRESENTATIVE WEEKS LATER.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 7150879 ↗
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- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.