Xia 3 System - Serrato 48261330Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327353167), received between Nov 1, 2017 and Nov 1, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2017Break; Fracture; 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: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6992888 ↗