Xia 3 System - Serrato 4826195100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327351750), received between Nov 1, 2017 and May 23, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2022Migration or Expulsion of Device; Insufficient Device Problem Information; Migration or Expulsion of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT A XIA 3 BLOCKER MIGRATED FROM A XIA SERRATO POLYAXIAL SCREW AT S2 APPROXIMATELY 1 YEAR POST-OPERATIVELY. IT IS NOT KNOWN AT THIS TIME IF REVISION SURGERY HAS BEEN SCHEDULED OR PERFORMED. THIS REPORT CAPTURES THE SCREW.

  Patient problems: Insufficient Information

  MAUDE report 14470886 ↗
• MalfunctionNov 29, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT THE SCREW BROKE DURING SURGERY, A PART OF SCREW WAS LEFT IN THE PATIENT. A SURGICAL DELAY OF 10 MINUTE WAS REPORTED. NO ADVERSE CONSEQUENCES TO THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8114493 ↗
• MalfunctionNov 1, 2017Break; Entrapment of Device; Fracture; Difficult to Remove; Fracture

  IT WAS REPORTED THAT A SCREW BECAME BOUND IN A PATIENTS BONE AND BROKE IN THE PROCESS OF TRYING TO REMOVE IT. IN ADDITION, A SCREWDRIVER ALSO BROKE IN THE PROCESS OF TRYING TO REMOVE THE SCREW.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6993539 ↗