Xia 3 System - Serrato 482619580Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327352047), received between Apr 19, 2018 and Dec 17, 2020 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE PUTTING THE SET SCREW ON, THE XIA SERRATO POLYAXIAL SCREW TULIP HEAD DISENGAGED INTRA-OPERATIVELY. ALL THE FRACTURED PIECES WERE REMOVED FROM THE SURGICAL SITE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11032257 ↗
• InjuryMar 30, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT THE SCREW WAS BROKEN POST-OPERATIVELY. A REVISION SURGERY WILL BE REQUIRED TO REPLACE THE SCREW.

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

  MAUDE report 8467462 ↗
• MalfunctionApr 19, 2018Mechanical Problem; Mechanical Problem; Device Slipped

  IT WAS REPORTED THAT DURING SURGERY, THE POLY-AXIAL PEDICLE SCREW TULIP HEAD DISENGAGED. IT WAS REMOVED AND REPLACE WITH THE SAME TYPE OF SCREW. ALL FRAGMENT WERE REMOVED. THERE WAS A REPORTED SURGICAL DELAY OF ONE HOUR. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT IN THIS EVENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7445123 ↗