Xia 3 System - Serrato 482617545Recalls & 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
- 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 07613327351408), received between Nov 22, 2017 and Sep 25, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
- Device Handling Problem2
- Migration1
Patient problems
- Bone Fracture(s)2
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE SHANK OF A XIA POLYAXIAL SCREW FRACTURED AND COULD NOT BE REMOVED FROM THE PATIENT. NO ADVERSE CONSEQUENCES WERE REPORTED. THE FRACTURED SCREW WAS OBSERVED IN A PLANNED REVISION SURGERY DUE TO ADJACENT INTERVERTEBRAL DISORDERS AND UNRELATED TO ANY ISSUE WITH THE DEVICE. IT IS UNKNOWN IF THE SCREW FRACTURED POST-OPERATIVELY OR INTRA-OPERATIVELY DURING THE REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20304374 ↗InjuryJun 5, 2023Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 6 MONTHS POST-OPERATIVELY TO ADDRESS A MIGRATED TRI PL CAGE AND A 'LOOSENED' XIA POLYAXIAL SCREW. THIS REPORT IS FOR THE XIA POLYAXIAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17058993 ↗MalfunctionNov 22, 2017Fracture; Device Handling Problem; Device Handling Problem
IT WAS REPORTED THAT; 7.5X45 SCREWS (TWO OF THEM AT L4 AND L5) FRACTURED THE PEDICLES. SCREWS REMAINED IN THE PATIENT AND CASE WAS COMPLETED.
Patient problems: Bone Fracture(s); Device Embedded In Tissue or Plaque
MAUDE report 7052307 ↗InjuryNov 22, 2017Fracture; Device Handling Problem; Device Handling Problem
IT WAS REPORTED THAT; 7.5X45 SCREWS (TWO OF THEM AT L4 AND L5) FRACTURED THE PEDICLES. SCREWS REMAINED IN THE PATIENT AND CASE WAS COMPLETED
Patient problems: Bone Fracture(s); Foreign Body In Patient
MAUDE report 7052219 ↗
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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