Xia 3 System - Serrato 482616540Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327351958), received between Oct 17, 2018 and Nov 7, 2025 — classified as 6 injuries.
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
- Migration2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Slipped1
- Migration or Expulsion of Device1
Patient problems
- Injury3
- Bone Fracture(s)2
- Back pain1
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2025Migration; Migration
A CUSTOMER REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY THREE WEEKS POST-OPERATIVELY TO ADDRESS A MIGRATED OIC PEEK SPACER. THE PATIENT REPORTED EXPERIENCING LOW BACK PAIN.
Patient problems: Back pain
MAUDE report 23499000 ↗InjuryOct 3, 2025Fracture; Fracture
InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING INTRA-OPERATIVE IMPLANT INSERTION A XIA SERRATO SCREW BROKE THE PATIENT'S PEDICLE . THE SCREW WAS LEFT IMPLANTED IN THE PATIENT. NO ADVERSE CONSEQUENCES, OR MEDICAL INTERVENTION WERE REPORTED. THE SURGEON NOTES THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY.
Patient problems: Bone Fracture(s)
MAUDE report 12094542 ↗InjuryMar 11, 2020Fracture; Fracture
IT WAS REPORTED THAT THE SURGEON IMPLANTED TWO SERRATO POLYAXIAL SCREWS AS INTENDED AND FOUND UPON INSERTION THAT THE L5 LEFT SIDED AND RIGHT SIDED PEDICLES FRACTURED UPON INSERTION. PATIENT EXPERIENCED BONE DAMAGE. THIS REPORT REPRESENTS THE 1ST OF THE 2 SCREWS.
Patient problems: Injury
MAUDE report 9819846 ↗InjuryMar 11, 2020Fracture; Fracture
IT WAS REPORTED THAT THE SURGEON IMPLANTED TWO SERRATO POLYAXIAL SCREWS AS INTENDED AND FOUND UPON INSERTION THAT THE L5 LEFT SIDED AND RIGHT SIDED PEDICLES FRACTURED UPON INSERTION. PATIENT EXPERIENCED BONE DAMAGE. THIS REPORT REPRESENTS THE 2ND OF THE 2 SCREWS.
Patient problems: Injury
MAUDE report 9819845 ↗InjuryOct 17, 2018Migration; Break; Migration or Expulsion of Device; Device Slipped; Migration
IT WAS REPORTED THAT THE POSTOPERATIVE CAGE MIGRATED AND REMOVED THE CAGE BY REOPERATION. THE RIGHT PEDICLE BROKE, AS A RESULT OF BROKEN BONE, L4 THE SCREW ON THE RIGHT WAS LOOSE AND RE-LOCKED BY CHANGING THE SCREW INSERTION DIRECTION.
Patient problems: Bone Fracture(s); Injury
MAUDE report 7974732 ↗
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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