XIA 4.5 System - XIA CT 488515030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327134148), received between Mar 2, 2018 and Sep 3, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2020Material Separation; Material Separation

  A PHYSICIAN REPORTED THAT THE, "HEAD POPPED OFF THE SHANK," OF A XIA CT POLYAXIAL SCREW APPROXIMATELY FIFTEEN-MONTHS POST-OPERATIVELY. THE PATIENT HAS RECEIVED MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10489416 ↗
• MalfunctionMar 2, 2018Device Dislodged or Dislocated; Detachment Of Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN L4-L5 FUSION, ALL SCREWS HAD BEEN SUCCESSFULLY IMPLANTED. THE SURGEON THEN TOOK THE PARALLEL POSTS AND POST DISTRACTOR TO DISTRACT AND PERFORM TLIF. HE THREADED THE POST ONTO THE L4 SCREW AND BEGAN TO TIGHTEN POST ONTO SCREW, AND THE TULIP HEAD ON THE SCREW DISENGAGED. A SCREWDRIVER WAS THEN USED TO REMOVE SHAFT OF SCREW AND A NEW SCREW WAS REINSERTED. SURGEON DISTRACTED OFF CONTRA-LATERAL SCREWS AND LOCKED A ROD IN PLACE TO COMPLETE DISCECTOMY AND TLIF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311380 ↗