XIA II 03821740Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant
All models of XIA II (34)
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 04546540149305), received between Sep 1, 2016 and Sep 1, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated2
- Mechanical Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2016Device Dislodged or Dislocated
IT WAS REPORTED THAT; DURING A REVISION, THE PATIENT HAD HARDWARE IN L4-S1. WE WERE EXTENDING THE HARDWARE UP TO L3. WHEN THE DOCTOR TOOK OUT OLD ROD AND STARTED TURNING THE HEADS ON THE SCREWS THAT WERE ALREADY IN THE PATIENT THREE TULIP HEADS POPPED OFF. WE REPLACED THEM WITH OTHER SCREWS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5920661 ↗MalfunctionSep 1, 2016Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem
IT WAS REPORTED THAT; DURING A REVISION, THE PATIENT HAD HARDWARE IN L4-S1. WE WERE EXTENDING THE HARDWARE UP TO L3. WHEN THE DOCTOR TOOK OUT OLD ROD AND STARTED TURNING THE HEADS ON THE SCREWS THAT WERE ALREADY IN THE PATIENT THREE TULIP HEADS POPPED OFF. WE REPLACED THEM WITH OTHER SCREWS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5920658 ↗
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 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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