Xia 3 System - Serrato 482618550Recalls & reported problems
Stryker Corporation · Polyaxial Screw · Class 2 · Implant
All models of Xia 3 System - Serrato (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327352344), received between May 26, 2021 and Feb 26, 2026 — classified as 1 injury, 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Fracture1
- Material Deformation1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Device Dislodged or Dislocated
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455764 ↗InjuryNov 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A COMPANY REPRESENTATIVE REPORTED THAT THE TULIP OF A XIA SERRATO POLYAXIAL SCREW DISENGAGED FROM THE SCREW SHANK INTRA-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE SCREW WAS REMOVED AND A LONGER SCREW WAS INSERTED INSTEAD. THE PROCEDURE WAS COMPLETED WITH A 10 MINUTE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20689648 ↗MalfunctionMay 26, 2021Fracture; Material Separation; Material Deformation; Fracture; Material Separation; Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT AN 8.5 X 50 MM SERRATO POLYAXIAL SCREW TULIP SPLAYED DURING INSERTION OF THE BLOCKER. THE TULIP THEN DISENGAGED FROM THE SCREW SHAFT WHEN THE SURGEON WENT TO REMOVE AND REPLACE THE BLOCKER. THE PHYSICIAN CHANGED OUT THE SCREW AND SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11885445 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- 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
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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