XIA 4 5 48145525Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540450159), received between May 22, 2017 and May 22, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Dislodged or Dislocated1
- Device Slipped1
- Material Integrity Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2017Device Slipped; Device Dislodged or Dislocated; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED A L4-5 FUSION USING CORTICAL SCREW TRAJECTORY. IT WAS REPORTED THAT DURING REGULAR FOLLOW UP, THE PATIENT X-RAYS SHOWED THAT THE SCREWS HAD PULLED OUT. IT WAS REPORTED THAT DURING THE REVISION SURGERY IT WAS DISCOVERED THAT THE SCREW HEAD HAD DISLODGED FROM THE SCREW SHAFT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6582394 ↗
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- Elegance® Anterior Cervical Plate 53430108Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430114Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430240Clariance · 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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