XIA II 03821750Recalls & 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 04546540149329), received between Sep 1, 2016 and May 8, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Detachment Of Device Component1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Material Separation1
- 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.
MalfunctionMay 8, 2018Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN A SCREW WAS IMPLANTED IN THE RIGHT S1 PEDICLE, AFTER ATTACHING ROD TO THE SADDLE WITH A BLOCKER - DURING MANIPULATION OF DISTRACTION TO COMPLETE DISCECTOMY AND INTERBODY DEVICE PLACEMENT, THE TULIP SEPARATED FROM THE SCREW SHANK. IT WAS DISCOVERED DURING X-RAY OF POST IMPLANTATION OF INTERBODY DEVICE. SCREW WAS THEN REMOVED WITH POLY HEAD ADJUSTER DRIVER, AND REPLACED WITH ANOTHER SCREW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7493405 ↗MalfunctionSep 1, 2016Detachment Of Device Component; Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device 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 5920662 ↗
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.
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