Xia 3 System - Serrato 482618580Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327351187), received between May 11, 2021 and Dec 16, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2021Material Separation; Detachment of Device or Device Component; Material Deformation; Material Separation; Detachment of Device or Device Component; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT, DURING IMPLANTATION OF A XIA SERRATO POLYAXIAL SCREW, THE TULIP DISENGAGED FROM THE SHAFT AND THE LOCKING RING IN THE TULIP DEFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022268 ↗
• MalfunctionMay 11, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TULIPS OF 3 XIA SERRATO POLYAXIAL SCREWS POPPED OFF THE SHANKS INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNSPECIFIED SURGICAL DELAY BY USING ALTERNATIVELY AVAILABLE IMPLANTS. THIS REPORT CAPTURES THE FIRST OF THE THREE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807125 ↗