XIA 4.5 Spinal System 48148545Recalls & reported problems
Stryker Corporation · Polyaxial Screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327132236), received between Nov 21, 2025 and Nov 21, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (4 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration4
Patient problems
- Insufficient Information4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2025Migration; Migration
A CUSTOMER REPORTED THAT A PATIENT WILL BE REVISED TO ADDRESS FOUR XIA 4.5 POLYAXIAL SCREW MIGRATIONS. THIS REPORT CAPTURES THE FOURTH OF FOUR SCREWS.
Patient problems: Insufficient Information
MAUDE report 23618870 ↗InjuryNov 21, 2025Migration; Migration
A CUSTOMER REPORTED THAT A PATIENT WILL BE REVISED TO ADDRESS FOUR XIA 4.5 POLYAXIAL SCREW MIGRATIONS. THIS REPORT CAPTURES THE FIRST OF FOUR SCREWS.
Patient problems: Insufficient Information
MAUDE report 23618693 ↗InjuryNov 21, 2025Migration; Migration
A CUSTOMER REPORTED THAT A PATIENT WILL BE REVISED TO ADDRESS FOUR XIA 4.5 POLYAXIAL SCREW MIGRATIONS. THIS REPORT CAPTURES THE SECOND OF FOUR SCREWS.
Patient problems: Insufficient Information
MAUDE report 23618680 ↗InjuryNov 21, 2025Migration; Migration
A CUSTOMER REPORTED THAT A PATIENT WILL BE REVISED TO ADDRESS FOUR XIA 4.5 POLYAXIAL SCREW MIGRATIONS. THIS REPORT CAPTURES THE THIRD OF FOUR SCREWS.
Patient problems: Insufficient Information
MAUDE report 23618620 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
- CD HORIZON® Spinal System 5540030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis230 reports
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- EXPEDIUM 179762480Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis114 reports
- ReLine 13550000Nuvasive, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis55 reports
- CD HORIZON® Spinal System 5440030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis50 reports
- EXPEDIUM 179712640Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis28 reports
- EXPEDIUM 179788635Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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