XIA II 03821645Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540149244), received between Jan 25, 2017 and Jul 1, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A SCHEDULED REVISION SURGERY TO REMOVE IMPLANTS IT WAS NOTICED THAT THE TIP OF A PREVIOUSLY IMPLANTED XIA POLYAXIAL SCREW AT L5 LEFT HAD FRACTURED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE TIP WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645133 ↗
• InjuryJan 5, 2024Fracture; Fracture

  A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A XIA POLYAXIAL SCREW FRACTURE ON THE LEFT SIDE OF L5. THE PATIENT REPORTED BACK PAIN AFTER 18 MONTHS FROM THE INITIAL SURGERY, AND SUBSEQUENT IMAGING IDENTIFIED THE FRACTURED SCREW.

  Patient problems: Pain

  MAUDE report 18460590 ↗
• InjuryJun 15, 2017Material Deformation; Difficult to Insert; Device Operates Differently Than Expected; Material Deformation

  IT WAS REPORTED THAT; WHEN DOCTOR USED THE SPREADER TO DISTRACT THE SCREWS ,HE FOUND THE REDUCTION POLYAXIAL SCREWS'S HEAD FIXED AND CANNOT MOVE ANY MORE. THE DOCTOR ACCORDING TO THE FIXED SCREW WAY USING THE SCREW. HOWEVER, CAUSED GREAT DIFFICULTIES OF INSTALLATION ROD, OPERATION TIME DELAY.

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

  MAUDE report 6645135 ↗
• MalfunctionJan 25, 2017Break; Fracture; Difficult to Remove; Material Integrity Problem; Fracture; Material Integrity Problem

  IT IS REPORTED THAT 5 YEARS AGO, THE PRODUCTS WERE IMPLANTED IN THE PATIENT. AFTER THAT, THE PRDUCTS WERE ATTEMPTED TO BE REMOVED ON (B)(6) 2016 AFTER SYNOSTOTIC. A BROKEN SCREW WAS CONFIMED AFTER REMOVING THE SCREW FROM AREA OF S1 R. THE BROKEN PART COULDN'T BE REMOVED AND IN PATIENT BODY. AND ATTEMPTED TO REMOVE THE SCREW OF L5 L, IT WAS ROCKED THE HEAD OF SCREW. IT WAS CONFIRMED THE BROKEN SCREW HEAD WAS ON THE TIP OF A MONODRIVER DURING UNLOCKING THE SCREW BY THE MONODRIVER.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6277942 ↗
• MalfunctionJan 25, 2017Break; Detachment Of Device Component; Mechanical Problem; Difficult to Remove; Detachment Of Device Component; Mechanical Problem

  IT IS REPORTED THAT 5 YEARS AGO, THE PRODUCTS WERE IMPLANTED IN THE PATIENT. AFTER THAT, THE PRODUCTS WERE ATTEMPTED TO BE REMOVED ON (B)(6) 2016 AFTER SYNOSTOTIC. A BROKEN SCREW WAS CONFIRMED AFTER REMOVING THE SCREW FROM AREA OF S1 R. THE BROKEN PART COULDN'T BE REMOVED AND IN PATIENT BODY. AND ATTEMPTED TO REMOVE THE SCREW OF L5 L, IT WAS ROCKED THE HEAD OF SCREW. IT WAS CONFIRMED THE BROKEN SCREW HEAD WAS ON THE TIP OF A MONO DRIVER DURING UNLOCKING THE SCREW BY THE MONO DRIVER.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6277941 ↗