XIA 4.5 System - XIA CT 488516535Recalls & reported problems
Stryker Corporation · Polyaxial Cortical Screw · Class 2 · Implant
All models of XIA 4.5 System - XIA CT (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327134667), received between Jun 6, 2018 and Jun 6, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (2 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.
Most reported problems
Device problems
- Migration2
- Migration or Expulsion of Device2
Patient problems
- Injury2
- No Code Available1
- 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.
InjuryJun 6, 2018Migration or Expulsion of Device; Migration; Migration
IT WAS REPORTED THAT 2 SCREWS PULLED OUT OF VERTEBRAL BODY AND INTERBODY CAGE MIGRATED FROM ORIGINAL POSITION. PATIENT REQUIRED REVISION SURGERY.
Patient problems: Injury; No Code Available
MAUDE report 7573024 ↗InjuryJun 6, 2018Migration or Expulsion of Device; Migration; Migration
IT WAS REPORTED THAT 2 SCREWS PULLED OUT OF VERTEBRAL BODY AND INTERBODY CAGE MIGRATED FROM ORIGINAL POSITION. PATIENT REQUIRED REVISION SURGERY.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 7573022 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
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- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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