XIA 3 482317580Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540562401), received between Feb 24, 2017 and Mar 7, 2023 — classified as 2 injuries.
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 Component1
- Device Dislodged or Dislocated1
- Fracture1
- Mechanical Problem1
Patient problems
- Injury1
- No Code Available1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 7, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A FRACTURED XIA 3 POLYAXIAL SCREW AT RIGHT-SIDE S1 AND A MIGRATED MANTIS REDUX BLOCKER AT LEFT-SIDE S1. THE PATIENT REPORTED EXPERIENCING LOW BACK PAIN AND INSTABILITY APPROXIMATELY TWO MONTHS POST-OPERATIVELY, AND IMAGING IDENTIFIED THE FRACTURE AND MIGRATION. THIS REPORT IS FOR THE XIA 3 POLYAXIAL SCREW.
Patient problems: Pain
MAUDE report 16495687 ↗InjuryFeb 24, 2017Break; Detachment Of Device Component; Mechanical Problem; Detachment Of Device Component; Mechanical Problem
IT WAS REPORTED THAT; ON (B)(6) 2016, THE PATIENT UNDERWENT THE SURGERY. THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE SCREW HEAD SEPARATED FROM THE SCREW SHAFT(S2AI). THEREFORE, THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2017.
Patient problems: Injury; No Code Available
MAUDE report 6358191 ↗
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- 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
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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