XIA II 03821650Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant
All models of XIA II (34)
Data updated Oct 18, 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 04546540149251), received between Jul 31, 2017 and Mar 25, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or 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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Operates Differently Than Expected1
- Material Deformation1
- Material Disintegration1
- Material Integrity Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionMar 25, 2022Material Separation; Detachment of Device or Device Component; Material Deformation; Material Separation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT THE TULIP OF A XIA II LP POLYAXIAL SCREW DISENGAGED INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER SCREW AND NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13904721 ↗MalfunctionJul 31, 2017Material Disintegration; Material Integrity Problem; Material Disintegration; Device Operates Differently Than Expected; Material Integrity Problem
IT WAS REPORTED THAT; OPERATION IS COMPLETED, NAILING WHEN INSTALLING A GREAT NAIL SCREW ROD FROM THE TAIL OUT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6755491 ↗
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- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
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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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