Xia 3 System - Serrato 482617550Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327352641), received between Nov 22, 2017 and Oct 13, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• InjuryOct 13, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH POSTERIOR FIXATION FROM T12 TO L3. APPROXIMATELY ONE YEAR AFTER INITIAL SURGERY, IT WAS OBSERVED THAT THE XIA POLYAXIAL SCREW AT L3 HAD "LOOSENED". THE PATIENT WAS REVISED TO REMOVE THE REPORTED SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628185 ↗
• MalfunctionNov 6, 2020Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING FINAL TIGHTENING OF A BLOCKER, THE XIA SERRATO POLYAXIAL SCREW TULIP DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10805040 ↗
• InjuryNov 22, 2017Fracture; Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT; 7.5X50 POLY SCREW FRACTURED PEDICLE DURING INSERTION. UPDATE 11/1/2017: SCREW REMAINS IMPLANTED SUCCESSFULLY IN PATIENT.

  Patient problems: Bone Fracture(s); No Known Impact Or Consequence To Patient

  MAUDE report 7052217 ↗