XIA 4 5 48146560Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540450302), received between Apr 25, 2017 and Apr 25, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
- Material Integrity Problem1
Patient problems
- Injury1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2017Device Operates Differently Than Expected; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT; AFTER THE FIRST OPERATION IT WAS DETERMINED THAT THE HEADS OF THE SCREW WERE REMOVED FROM THE SCREW IN THE RESULT OF THE PATIENT'S APPLICATION TO THE CLINIC WITH THE PAIN AND IT WAS CHANGED WITH THE SCREWS IN THE REVISION SURGERY.
Patient problems: Injury; Pain
MAUDE report 6518668 ↗
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- Elegance® Anterior Cervical Plate 53430114Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
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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 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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