XIA 3 482319590Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant
All models of XIA 3 (93)
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 04546540598868), received between Sep 8, 2017 and Mar 6, 2018 — classified as 2 malfunctions.
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. 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 Dislocated1
- Device Operates Differently Than Expected1
- Disconnection1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2018Disconnection; Disconnection; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE SURGEON WAS FINAL TIGHTENING THE BLOCKER ON THE PELVIC SCREW, AND THE HEAD OF THE SCREW POPPED OFF. THE ROD WAS SEATED IN THE LATERAL CONNECTOR THAT WAS CONNECTED TO THE PELVIC SCREW. HE THEN REMOVED THE SCREW AND REPLACED WITH ANOTHER ONE. DELAY IN SURGERY OF 10 MINUTES. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7318822 ↗MalfunctionSep 8, 2017Material Deformation; Device Operates Differently Than Expected; Material Deformation
IT WAS REPORTED THAT; WE WERE TRYING TO TIGHTEN DOWN A BLOCKER. WHEN WE ATTEMPTED TO DISTRACT AND THEN TIGHTEN THE BLOCKER THE BLOCKER WOULD BECOME CROSS THREADED APRON RE TIGHTENING. I BELIEVE THE TULIP HEAD OF THE SCREW BECAME SPLAYED. WE REMOVED THE SCREW AND REPLACED IT AND WERE ABLE TO FINISH THE CASE.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 6852704 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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.
How reports and recalls are matched · Editorial policy · Report an error on this page