Xia 3 System - Serrato 482617050Recalls & 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
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327351507), received between Mar 29, 2019 and Mar 29, 2019 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (4 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.
Most reported problems
Device problems
- Migration4
- Appropriate Device Problem Term/Code Not Available3
- Loose or Intermittent Connection3
- Device Slipped1
Patient problems
- Injury4
- Pain4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Migration; Migration
IT WAS REPORTED THAT THE SCREW WAS FOUND TO BE LOOSE. THE PATIENT WAS IN PAIN AND REVISION SURGERY WAS PERFORMED FOR REPLACEMENT OF HARDWARE, UPSIZE SCREWS AND FUSE POSTERIOR LATERAL.
Patient problems: Injury; Pain
MAUDE report 8467186 ↗InjuryMar 29, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Migration; Migration
IT WAS REPORTED THAT THE SCREW WAS FOUND TO BE LOOSE. THE PATIENT WAS IN PAIN AND REVISION SURGERY WAS PERFORMED FOR REPLACEMENT OF HARDWARE, UPSIZE SCREWS AND FUSE POSTERIOR LATERAL.
Patient problems: Injury; Pain
MAUDE report 8467185 ↗InjuryMar 29, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Migration; Migration
IT WAS REPORTED THAT THE SCREW WAS FOUND TO BE LOOSE. THE PATIENT WAS IN PAIN AND REVISION SURGERY WAS PERFORMED FOR REPLACEMENT OF HARDWARE, UPSIZE SCREWS AND FUSE POSTERIOR LATERAL.
Patient problems: Injury; Pain
MAUDE report 8467183 ↗InjuryMar 29, 2019Device Slipped; Migration; Migration
IT WAS REPORTED THAT THE SCREW WAS FOUND TO BE LOOSE. THE PATIENT WAS IN PAIN AND REVISION SURGERY WAS PERFORMED FOR REPLACEMENT OF HARDWARE, UPSIZE SCREWS AND FUSE POSTERIOR LATERAL.
Patient problems: Injury; Pain
MAUDE report 8467181 ↗
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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