XIA II 03821755Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540149336), received between May 27, 2021 and Sep 1, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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 1, 2021Fracture; Material Separation; Detachment of Device or Device Component; Fracture; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN AND IMAGING REVEALED A FRACTURED XIA II LP POLYAXIAL SCREW, A FRACTURED XIA II ROD, AND A XIA 3 TITANIUM POLYAXIAL SCREW WITH "HEAD PULL OUT." THE PATIENT UNDERWENT REVISION SURGERY. THE BODY OF THE XIA 3 TITANIUM POLYAXIAL SCREW WAS NOT ABLE TO BE REMOVED AND REMAINS IMPLANTED IN THE PATIENT'S ILIUM. THIS REPORT CAPTURES THE XIA II LP SCREW.

  Patient problems: Pain

  MAUDE report 12407757 ↗
• InjuryMay 27, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  A PATIENT PRESENTED WITH PAIN, A SUBSEQUENT X-RAY REVEALED THAT THE TULIP OF A XIA II LP POLYAXIAL SCREW DISENGAGED FROM THE SCREW SHAFT POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 11893646 ↗