Xia 3 System - Serrato 482678580Recalls & reported problems
Stryker Corporation · Medial Biased-Angle 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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327351873), received between Mar 4, 2019 and Jan 13, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated2
- Break1
- Fracture1
- Misassembled1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Spinal Column Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 13, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A XIA SERRATO POLYAXIAL SCREW TULIP DISENGAGEMENT, WHICH WAS IDENTIFIED ON POST-OPERATIVE IMAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064055 ↗InjuryMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
MalfunctionDec 16, 2020Misassembled; Misassembled
IT WAS REPORTED THAT A XIA SERRATO POLYAXIAL SCREW WAS NOT ABLE TO BE FULLY FINAL TIGHTENED INTRA-OPERATIVELY. THE SURGEON LEFT THE SCREW AS IS AND COMPLETED THE PROCEDURE. NO ADVERSE CONSEQUENCES OR SURGICAL DELAYS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11016218 ↗MalfunctionMar 4, 2019Break; Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE TULIP OF SCREW DISSOCIATED WHILE PLACING BLOCKER. A SURGICAL DELAY OF 8 MINUTE WAS REPORTED TO REPLACE THE SCREW. ALL BROKEN FRAGMENTS WERE RETRIEVED. THE SURGERY WAS COMPLETED USING THE SAME BLOCKER. NO OTHER CONSEQUENCE WAS REPORTED TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8385948 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page