Xia 3 System - Serrato 482627540Recalls & reported problems
Stryker Corporation · Reduction 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327351163), received between Sep 2, 2020 and Sep 2, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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.
Most reported problems
Device problems
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT A SERRATO REDUCTION POLYAXIAL SCREW TULIP AND THE THREADS OF TWO XIA 3 TITANIUM BLOCKERS DEFORMED INTRA-OPERATIVELY. WHILE TIGHTENING THE BLOCKER ON THE REDUCTION SCREW, THE SURGEON HEARD THE SOUND OF THE TAB OF THE UNIVERSAL TIGHTENER BREAKING. IT WAS DISCOVERED THAT THE THREAD OF THE SCREW HEAD WAS DEFORMED AND THE BLOCKER WAS CROSS THREADED. THE BLOCKER WAS NOT ABLE TO BE INSTALLED IN THE CORRECT POSITION. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY BY REPLACING THE SCREW AND BLOCKERS WITH NEW ONES. THERE WERE NO ADVERSE CONSEQUENCES WITH THE PATIENT AND NO SURGICAL DELAY. ADDITIONAL REVIEW OF THE DEVICES INDICATES THAT ONLY ONE OF THE TWO BLOCKERS WAS DEFORMED. THIS RECORD REPRESENTS THE POLYAXIAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10485580 ↗
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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