Xia 3 System - Serrato 482618570Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327351736), received between Jul 22, 2019 and May 11, 2021 — classified as 2 injuries, 2 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 SECOND OF THE THREE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807135 ↗
• 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 11807120 ↗
• InjuryOct 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE TULIP OF A XIA SERRATO POLYAXIAL SCREW LOCATED AT S5 "CAME APART" FROM THE SHAFT POST-OPERATIVELY. REVISION SURGERY HAS BEEN PERFORMED WHERE THE SCREW WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10693098 ↗
• InjuryJul 22, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY(B)(6) 2019 FOR THE REMOVAL OF AN S1 SERRATO SCREW WHICH "CAME OFF" POST-OPERATIVELY. THIS RECORD IS RELATED TO MANUFACTURER'S INCIDENT REPORT 3005525032-2019-00069.

  Patient problems: Injury

  MAUDE report 8812182 ↗