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Xia 3 System - Serrato 482677580Recalls & 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
5
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327351699), received between Apr 3, 2020 and Oct 5, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Device problems

  • Detachment of Device or Device Component3
  • Material Separation3
  • Device Dislodged or Dislocated1
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • Unspecified Infection1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 5, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

    IT WAS REPORTED THAT TWO XIA SERRATO POLYAXIAL SCREW TULIPS DISENGAGED POST-OPERATIVELY. REVISION SURGERY IS NOT PLANNED AT THIS TIME. THIS REPORT CAPTURES THE SECOND OF THE TWO SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12576904 ↗
  • MalfunctionOct 5, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

    IT WAS REPORTED THAT TWO XIA SERRATO POLYAXIAL SCREW TULIPS DISENGAGED POST-OPERATIVELY. REVISION SURGERY IS NOT PLANNED AT THIS TIME. THIS REPORT CAPTURES THE FIRST OF THE TWO SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12576892 ↗
  • MalfunctionApr 1, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING FINAL TIGHTENING A XIA SERRATO POLYAXIAL SCREW TULIP DISENGAGED FROM THE SCREW SHAFT INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11602977 ↗
  • InjuryMar 1, 2021Material Separation; Material Separation

    IT WAS REPORTED THAT TWO XIA SERRATO MEDIAL BIASED POLYAXIAL SCREWS "POPPED-OUT" 5 MONTHS POST-OPERATIVELY. REVISION HAS BEEN PERFORMED. THIS REPORT WILL CAPTURE THE FIRST OF TWO SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11396702 ↗
  • InjuryApr 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT A SERRATO POLYAXIAL SCREW TULIP DISENGAGED POST-OPERATIVELY. THE TULIP DISENGAGEMENT WAS DISCOVERED DURING A REVISION SURGERY THAT WAS BEING PERFORMED FOR A SUSPECTED INFECTION. IT IS UNKNOWN WHAT CAUSED THE INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 9925191 ↗

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Sources and updates

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