XIA II 03821655Recalls & 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
- 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 04546540149268), received between Sep 26, 2018 and Sep 26, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
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.
MalfunctionSep 26, 2018Break; Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component
IT WAS REPORTED THAT AFTER INSERTION OF THE RIGHT SIDE NAIL WITH BLOCKER, SCREW PULL OUT WAS CONFIRMED IN IMAGE EXAMINATION. THE SCREW HAS BEEN REMOVED AND REPLACED. WHEN THE LEFT SIDE NAIL AND SCREW WERE PLACED, IT ALSO PULLED OUT DURING COMPRESSION; THE SCREW WAS REMOVED AND REPLACED BY ANOTHER, WHICH HAD THE HEAD LOCKED. THE DOCTOR REMOVED THE SCREW AND CHOSE NOT TO PUT ANOTHER. IT WAS FURTHER REPORTED THAT ONE OF THE SCREWS DID PULL OUT OF THE HEAD AND AFTER PULLOUT VERIFIED, IT WAS NOTICED THAT THE RING ON THE INSIDE OF THE SCREW HAD BROKEN WITHOUT LARGE LOOSE FRAGMENTS. THE SURGICAL INCISION WAS WASHED. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7910827 ↗
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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